**Firm:** MAX LOOK CONTACT LENS / KIM

**Import alert:** 86-11

**Import alert name:** "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination"

**Country:** KOREA (THE REPUBLIC OF)

**Address:** 105 Hyeopseok-Ri , Namcheon-Myeon , Gyeongsan, Gyeongsangbugdo KOREA (THE REPUBLIC OF)

**Date published:** 10/17/2013

**Product code:** 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight

**Product:** Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses

**FDA notes:** Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II

> MAX LOOK CONTACT LENS / KIM Date Published : 10/17/2013 105 Hyeopseok-Ri , Namcheon-Myeon , Gyeongsan, Gyeongsangbugdo KOREA (THE REPUBLIC OF) 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 M - - VN Lens, Contact (Disposable) Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II 86 N - - UU Lens, Contact, Orthokeratology, Overnight Date Published: 10/17/2013 Desc: Contact Lenses Notes: Class II

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1133.html>

MAX LOOK CONTACT LENS / KIM — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Achlim Trading Sdn Bhd

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 1-113a Plaza Idaman , Jalan Gombak; MEDAN IDAMAN , Kuala Lumpur, Wilayah Persekutuan MALAYSIA

**Date published:** 09/07/2016

**Product code:** 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** KINGDOM HONEY FOR HER | KINGDOM ROYAL HONEY | Royal Honey VIP | KINGDOM HONEY FOR HIM | Royal Honey VIP | Etumax Royal Honey For Him | KINGDOM HONEY FOR HER | KINGDOM HONEY FOR HIM | KINGDOM ROYAL HONEY | Royal Honey VIP | KINGDOM HONEY FOR HER | KINGDOM HONEY FOR HIM | KINGDOM ROYAL HONEY | Royal Honey VIP | Etumax Royal Honey For Him | Etumax Royal Honey For Him | Etumax Royal Honey For Him | KINGDOM HONEY FOR HIM | KINGDOM ROYAL HONEY | KINGDOM HONEY FOR HER

**FDA notes:** Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis

> Achlim Trading Sdn Bhd Date Published : 09/07/2016 1-113a Plaza Idaman , Jalan Gombak; MEDAN IDAMAN , Kuala Lumpur, Wilayah Persekutuan MALAYSIA 36 C - - 04 Honey Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HER Notes: Product contains Tadalafil per FDA analysis 36 C - - 04 Honey Date Published: 07/10/2017 Desc: KINGDOM ROYAL HONEY Notes: Product contains Tadalafil per FDA analysis 36 C - - 04 Honey Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 36 C - - 04 Honey Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HIM Notes: Product contains Tadalafil per FDA analysis 36 C - - 99 Honey, N.E.C. Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/07/2016 Desc: Etumax Royal Honey For Him Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HER Notes: Product contains Tadalafil per FDA analysis 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HIM Notes: Product contains Tadalafil per FDA analysis 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 07/10/2017 Desc: KINGDOM ROYAL HONEY Notes: Product contains Tadalafil per FDA analysis 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HER Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HIM Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/10/2017 Desc: KINGDOM ROYAL HONEY Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/07/2016 Desc: Etumax Royal Honey For Him Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. 66 S - - 51 Tadalafil Date Published: 09/07/2016 Desc: Etumax Royal Honey For Him Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/07/2016 Desc: Etumax Royal Honey For Him Notes: Problem(s); FDA laboratory analysis confirmed product contains undeclared tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HIM Notes: Product contains Tadalafil per FDA analysis 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2017 Desc: KINGDOM ROYAL HONEY Notes: Product contains Tadalafil per FDA analysis 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2017 Desc: KINGDOM HONEY FOR HER Notes: Product contains Tadalafil per FDA analysis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Achlim Trading Sdn Bhd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Biotivity SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Lot 6384 , Jalan Gelung Pepuyu , Bota, Perak MALAYSIA

**Date published:** 06/29/2017

**Product code:** 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

**Product:** Royal Honey VIP | Royal Honey VIP | Royal Honey VIP | Royal Honey VIP

**FDA notes:** Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis

> Biotivity SDN BHD Date Published : 06/29/2017 Lot 6384 , Jalan Gelung Pepuyu , Bota, Perak MALAYSIA 36 C - - 04 Honey Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 36 C - - 99 Honey, N.E.C. Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/29/2017 Desc: Royal Honey VIP Notes: Product contains Tadalafil per FDA analysis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Biotivity SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** CAVERFLO TEXAS TRADING

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA

**Date published:** 09/26/2017

**Product code:** 31 A - - -- Coffee | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** CaverFlo Natural Herbal Coffee | CaverFlo Natural Herbal Coffee | CaverFlo Natural Herbal Coffee | CaverFlo Natural Herbal Coffee

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil | FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil

> CAVERFLO TEXAS TRADING Date Published : 09/26/2017 117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA 31 A - - -- Coffee Date Published: 09/26/2017 Desc: CaverFlo Natural Herbal Coffee Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/26/2017 Desc: CaverFlo Natural Herbal Coffee Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 09/26/2017 Desc: CaverFlo Natural Herbal Coffee Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/26/2017 Desc: CaverFlo Natural Herbal Coffee Notes: FDA laboratory analysis confirmed product contains undeclared Desmethyl Carbodenafil; an analogue of Sildenafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

CAVERFLO TEXAS TRADING — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Dose Vital Manufacturing SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** No. 8a Jalan Kelang Lama , Kuala Lumpur, Wilayah Persekutuan MALAYSIA

**Date published:** 06/08/2018

**Product code:** 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

**Product:** Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement

**FDA notes:** Product was found to contain undeclared Tadalafil. | Product was found to contain undeclared Tadalafil. | Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil

> Dose Vital Manufacturing SDN BHD Date Published : 06/08/2018 No. 8a Jalan Kelang Lama , Kuala Lumpur, Wilayah Persekutuan MALAYSIA 36 C - - 04 Honey Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil. 36 C - - 99 Honey, N.E.C. Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Dose Vital Manufacturing SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Dr Foerster (M) Sdn Bhd

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** No. 95 Jalan Nilam 1/2 , Taman Technologi Tinggi Subang , Shah Alam, Selangor MALAYSIA

**Date published:** 11/27/2018

**Product code:** 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** Dr Foerster Detox Plus Food Supplement | Dr Foerster Detox Plus Food Supplement | Ultra Detox Capsules | Ultra Detox Capsules | Ultra Detox Capsules

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine. | FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine. | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil

> Dr Foerster (M) Sdn Bhd Date Published : 11/27/2018 No. 95 Jalan Nilam 1/2 , Taman Technologi Tinggi Subang , Shah Alam, Selangor MALAYSIA 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 12/23/2019 Desc: Dr Foerster Detox Plus Food Supplement Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 12/23/2019 Desc: Dr Foerster Detox Plus Food Supplement Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil, paynantheine and, mitragynine. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil 66 S - - 51 Tadalafil Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Dr Foerster (M) Sdn Bhd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** DRS SECRET WORLDWIDE MANUFACTURING SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** No 42 Jalan Todak , 2 , Seberang Perai Tengah, Pulau Pinang MALAYSIA

**Date published:** 05/19/2016

**Product code:** 31 A - - -- Coffee | 36 C - - 04 Honey | 36 C - - 04 Honey | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** DR's SECRET BIO HERBS COFFEE | Royal King Honey (Food Supplement) | Mens Bio Honey Malaysia Recipe | Mens Bio Honey Malaysia Recipe | Royal King Honey (Food Supplement) | Mens Bio Honey Malaysia Recipe | Royal King Honey (Food Supplement) | DR's SECRET BIO HERBS COFFEE | Royal King Honey (Food Supplement) | Mens Bio Honey Malaysia Recipe

**FDA notes:** Problem(s); Product contains Tadalafil per FDA analysis. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Problem(s); Product contains Tadalafil per FDA analysis. | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil | Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

> DRS SECRET WORLDWIDE MANUFACTURING SDN BHD Date Published : 05/19/2016 No 42 Jalan Todak , 2 , Seberang Perai Tengah, Pulau Pinang MALAYSIA 31 A - - -- Coffee Date Published: 05/19/2016 Desc: DR's SECRET BIO HERBS COFFEE Notes: Problem(s); Product contains Tadalafil per FDA analysis. 36 C - - 04 Honey Date Published: 05/24/2016 Desc: Royal King Honey (Food Supplement) Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil. 36 C - - 04 Honey Date Published: 05/24/2016 Desc: Mens Bio Honey Malaysia Recipe Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/24/2016 Desc: Mens Bio Honey Malaysia Recipe Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/24/2016 Desc: Royal King Honey (Food Supplement) Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 05/24/2016 Desc: Mens Bio Honey Malaysia Recipe Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 05/24/2016 Desc: Royal King Honey (Food Supplement) Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil 66 S - - 51 Tadalafil Date Published: 05/19/2016 Desc: DR's SECRET BIO HERBS COFFEE Notes: Problem(s); Product contains Tadalafil per FDA analysis. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/24/2016 Desc: Royal King Honey (Food Supplement) Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/24/2016 Desc: Mens Bio Honey Malaysia Recipe Notes: Product was found to contain undeclared Thiosildenafil and Hydroxythiohomosildenafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

DRS SECRET WORLDWIDE MANUFACTURING SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** EXPO CONNECT SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Street Mall One South , Seri Kembangan, Selangor MALAYSIA

**Date published:** 06/26/2019

**Product code:** 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

**Product:** Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey) | Helmi's Honey VIP Jantanak Dream (Royal Honey)

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | Helmi's Honey VIP Jantanak Dream (Royal Honey); FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil.

> EXPO CONNECT SDN BHD Date Published : 06/26/2019 Street Mall One South , Seri Kembangan, Selangor MALAYSIA 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses Date Published: 06/26/2019 Desc: Helmi's Honey VIP Jantanak Dream (Royal Honey) Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 06/26/2019 Desc: Helmi's Honey VIP Jantanak Dream (Royal Honey) Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 06/26/2019 Notes: Helmi's Honey VIP Jantanak Dream (Royal Honey); FDA laboratory analysis confirmed product contains undeclared Tadalafil. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 06/26/2019 Desc: Helmi's Honey VIP Jantanak Dream (Royal Honey) Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 66 S - - 51 Tadalafil Date Published: 06/26/2019 Desc: Helmi's Honey VIP Jantanak Dream (Royal Honey) Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/26/2019 Desc: Helmi's Honey VIP Jantanak Dream (Royal Honey) Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 06/26/2019 Desc: Helmi's Honey VIP Jantanak Dream (Royal Honey) Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

EXPO CONNECT SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Fikrysz

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 14 Lorong Saga , Sungai Petani, MALAYSIA

**Date published:** 04/14/2023

**Product code:** 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

**Product:** Natural Herbs Coffee

**FDA notes:** Product contains Sildenafil and Tadalafil per FDA analysis

> Fikrysz Date Published : 04/14/2023 14 Lorong Saga , Sungai Petani, MALAYSIA 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 04/14/2023 Desc: Natural Herbs Coffee Notes: Product contains Sildenafil and Tadalafil per FDA analysis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Fikrysz — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** GOLD FOOD RESOURCES SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Lot 331 Perusahaan Buloh 3 , Ipoh, MALAYSIA

**Date published:** 03/17/2023

**Product code:** 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 S - - 51 Tadalafil

**Product:** BLACK HORSE VITAL HONEY | BLACK HORSE VITAL HONEY | BLACK HORSE VITAL HONEY | BLACK HORSE VITAL HONEY

**FDA notes:** Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis | Product contains Tadalafil per FDA analysis

> GOLD FOOD RESOURCES SDN BHD Date Published : 03/17/2023 Lot 331 Perusahaan Buloh 3 , Ipoh, MALAYSIA 36 C - - 04 Honey Date Published: 03/17/2023 Desc: BLACK HORSE VITAL HONEY Notes: Product contains Tadalafil per FDA analysis 36 C - - 99 Honey, N.E.C. Date Published: 03/17/2023 Desc: BLACK HORSE VITAL HONEY Notes: Product contains Tadalafil per FDA analysis 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 03/17/2023 Desc: BLACK HORSE VITAL HONEY Notes: Product contains Tadalafil per FDA analysis 66 S - - 51 Tadalafil Date Published: 03/17/2023 Desc: BLACK HORSE VITAL HONEY Notes: Product contains Tadalafil per FDA analysis

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

GOLD FOOD RESOURCES SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** HERAMIOS SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 5-17 Jalan Pju 1a/7 , Petaling Jaya, Selangor MALAYSIA

**Date published:** 06/08/2018

**Product code:** 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

**Product:** Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement | Vital Honey with Caviar and Tongkat All Powder Dietary Supplement

**FDA notes:** Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil. | Product was found to contain undeclared Tadalafil.

> HERAMIOS SDN BHD Date Published : 06/08/2018 5-17 Jalan Pju 1a/7 , Petaling Jaya, Selangor MALAYSIA 36 C - - 04 Honey Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil 36 C - - 99 Honey, N.E.C. Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil. 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 06/08/2018 Desc: Vital Honey with Caviar and Tongkat All Powder Dietary Supplement Notes: Product was found to contain undeclared Tadalafil.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

HERAMIOS SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** KHAN aLASSAL

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Unknown , Selangor, UNKNOWN MALAYSIA

**Date published:** 05/10/2019

**Product code:** 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts | Gold Herbs Royal King Honey with Herbal Extracts

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | Gold Herbs Royal King Honey with Herbal Extracts; Note: FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil.

> KHAN aLASSAL Date Published : 05/10/2019 Unknown , Selangor, UNKNOWN MALAYSIA 36 C - - 04 Honey Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 36 C - - 99 Honey, N.E.C. Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 Y - - 10 Royal Jelly (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 05/10/2019 Notes: Gold Herbs Royal King Honey with Herbal Extracts; Note: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 66 S - - 51 Tadalafil Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/10/2019 Desc: Gold Herbs Royal King Honey with Herbal Extracts Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

KHAN aLASSAL — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** KINGDOM ETUMAX BIO SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Seksy , 102 Jalan Gasing , Petaling, Selangor MALAYSIA

**Date published:** 05/02/2023

**Product code:** 36 C - - -- Honey | 36 C - - -- Honey | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** Kingdom Honey Royal Honey | Etumax Royal Honey | Kingdom Honey Royal Honey | Etumax Royal Honey

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil.

> KINGDOM ETUMAX BIO SDN BHD Date Published : 05/02/2023 Seksy , 102 Jalan Gasing , Petaling, Selangor MALAYSIA 36 C - - -- Honey Date Published: 05/02/2023 Desc: Kingdom Honey Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil. 36 C - - -- Honey Date Published: 05/08/2023 Desc: Etumax Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/02/2023 Desc: Kingdom Honey Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/08/2023 Desc: Etumax Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

KINGDOM ETUMAX BIO SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Kingdom Honey SDN. BHD.

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 569-364 Sentul Boulevard , Jalan Matang 3 , Kuala Lumpur, Wilayah Persekutuan MALAYSIA

**Date published:** 03/26/2019

**Product code:** 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** Royal Honey | Royal Honey | Royal Honey | Royal Honey | Royal Honey | Royal Honey

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | Royal Honey; Note: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 4/01/2019 | FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website.

> Kingdom Honey SDN. BHD. Date Published : 03/26/2019 569-364 Sentul Boulevard , Jalan Matang 3 , Kuala Lumpur, Wilayah Persekutuan MALAYSIA 36 C - - 04 Honey Date Published: 03/26/2019 Desc: Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 36 C - - 99 Honey, N.E.C. Date Published: 03/26/2019 Desc: Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/26/2019 Desc: Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 03/26/2019 Desc: Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 03/26/2019 Notes: Royal Honey; Note: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 66 S - - 51 Tadalafil Date Published: 06/26/2019 Desc: Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website. 4/01/2019 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/26/2019 Desc: Royal Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. Claims noted on product website.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Kingdom Honey SDN. BHD. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Medcare Smart SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 21-1 Jalan kg Pandan , Taman Maluri 55100 , Kuala, Lampur MALAYSIA

**Date published:** 09/22/2016

**Product code:** 36 C - - 04 Honey | 66 S - - 51 Tadalafil

**Product:** Golden Royal Honey | Golden Royal Honey

**FDA notes:** Product was found to contain undeclared Tadalafil | Product was found to contain undeclared Tadalafil

> Medcare Smart SDN BHD Date Published : 09/22/2016 21-1 Jalan kg Pandan , Taman Maluri 55100 , Kuala, Lampur MALAYSIA 36 C - - 04 Honey Date Published: 09/22/2016 Desc: Golden Royal Honey Notes: Product was found to contain undeclared Tadalafil 66 S - - 51 Tadalafil Date Published: 09/22/2016 Desc: Golden Royal Honey Notes: Product was found to contain undeclared Tadalafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Medcare Smart SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** NATURAL ELIXIRS SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** No 17 Jalan Selat Selat , Pelabuhan Klang, MALAYSIA

**Date published:** 11/27/2018

**Product code:** 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** Ultra Detox Capsules | Ultra Detox Capsules | Ultra Detox Capsules

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil | FDA laboratory analysis confirmed product contains undeclared tadalafil

> NATURAL ELIXIRS SDN BHD Date Published : 11/27/2018 No 17 Jalan Selat Selat , Pelabuhan Klang, MALAYSIA 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil 66 S - - 51 Tadalafil Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

NATURAL ELIXIRS SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Natural Elixirs

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 6 Jalan Jasmin , Selangor, MALAYSIA

**Date published:** 05/04/2017

**Product code:** 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 S - - 51 Tadalafil | 66 S - - 51 Tadalafil | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** GRANDE PLATINUM - BINDII | Ultra Detox Capsules | Ultra Detox Capsules | GRANDE PLATINUM - BINDII | Ultra Detox Capsules

**FDA notes:** Product was found to contain undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil | Product was found to contain undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil

> Natural Elixirs Date Published : 05/04/2017 6 Jalan Jasmin , Selangor, MALAYSIA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/04/2017 Desc: GRANDE PLATINUM - BINDII Notes: Product was found to contain undeclared Tadalafil. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil. 66 S - - 51 Tadalafil Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil 66 S - - 51 Tadalafil Date Published: 05/04/2017 Desc: GRANDE PLATINUM - BINDII Notes: Product was found to contain undeclared Tadalafil. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 11/27/2018 Desc: Ultra Detox Capsules Notes: FDA laboratory analysis confirmed product contains undeclared tadalafil

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Natural Elixirs — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** SUPERFOOD INTERNATIONAL SDN BHD

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Lot 23 Prai Industrial , Penang, MALAYSIA

**Date published:** 01/31/2022

**Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

**Product:** VITAMAX DOUBLESHOT Energy Honey | VITAMAX DOUBLESHOT Energy Honey

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared Tadalafil. | FDA laboratory analysis confirmed product contains undeclared Tadalafil.

> SUPERFOOD INTERNATIONAL SDN BHD Date Published : 01/31/2022 Lot 23 Prai Industrial , Penang, MALAYSIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/31/2022 Desc: VITAMAX DOUBLESHOT Energy Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 01/31/2022 Desc: VITAMAX DOUBLESHOT Energy Honey Notes: FDA laboratory analysis confirmed product contains undeclared Tadalafil.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

SUPERFOOD INTERNATIONAL SDN BHD — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Worldgate Vision Beverage Sdn Bhd

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** Kawasan Perusahaan Sungai Tukang , 95 Lorong Enggang 6 , Kuala Muda, Kedah MALAYSIA

**Date published:** 08/05/2016

**Product code:** 31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts) | 31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts) | 31 - - - -- Coffee/Tea | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 65 P - - 02 Sildenafil Citrate (Regulator) | 65 P - - 99 Regulator N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc.

**Product:** STIFF BULL HERBAL COFFEE | Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | STIFF BULL HERBAL COFFEE | Natural Herbs Coffee

**FDA notes:** Product was found to contain undeclared Desmethyl carbodenafil | Product was found to contain undeclared Desmethyl carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Product was found to contain undeclared Desmethyl carbodenafil | Product was found to contain undeclared Desmethyl carbodenafil.

> Worldgate Vision Beverage Sdn Bhd Date Published : 08/05/2016 Kawasan Perusahaan Sungai Tukang , 95 Lorong Enggang 6 , Kuala Muda, Kedah MALAYSIA 31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts) Date Published: 09/20/2016 Desc: STIFF BULL HERBAL COFFEE Notes: Product was found to contain undeclared Desmethyl carbodenafil 31 E - - 06 Herbal Coffee (Blend of herbs, grains, fruits and nuts) Date Published: 08/05/2016 Desc: Natural Herbs Coffee Notes: Product was found to contain undeclared Desmethyl carbodenafil. 31 - - - -- Coffee/Tea Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. 65 P - - 99 Regulator N.E.C. Date Published: 09/20/2016 Desc: STIFF BULL HERBAL COFFEE Notes: Product was found to contain undeclared Desmethyl carbodenafil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/05/2016 Desc: Natural Herbs Coffee Notes: Product was found to contain undeclared Desmethyl carbodenafil.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Worldgate Vision Beverage Sdn Bhd — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Yong Fatt Vision T

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 16 A431 Lorong , Sungai Petani, Kedah MALAYSIA

**Date published:** 09/19/2017

**Product code:** 31 - - - -- Coffee/Tea | 54 F - - -- Herbal & Botanicals(other than teas) | 65 P - - 02 Sildenafil Citrate (Regulator)

**Product:** Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee

**FDA notes:** Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;

> Yong Fatt Vision T Date Published : 09/19/2017 16 A431 Lorong , Sungai Petani, Kedah MALAYSIA 31 - - - -- Coffee/Tea Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Yong Fatt Vision T — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Yongfatt Vision Tr

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MALAYSIA

**Address:** 95 Jalan Enggang , Sungai Petani, Kedah MALAYSIA

**Date published:** 09/19/2017

**Product code:** 31 - - - -- Coffee/Tea | 54 F - - -- Herbal & Botanicals(other than teas) | 65 P - - 02 Sildenafil Citrate (Regulator)

**Product:** Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee | Kopi Jantan Tradisional Natural Herbs Coffee

**FDA notes:** Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; ; 9/18/2017 | Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;

> Yongfatt Vision Tr Date Published : 09/19/2017 95 Jalan Enggang , Sungai Petani, Kedah MALAYSIA 31 - - - -- Coffee/Tea Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 06/26/2019 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil; ; 9/18/2017 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 09/19/2017 Desc: Kopi Jantan Tradisional Natural Herbs Coffee Notes: Problem(s); Product was found to contain undeclared Desmethyl Carbodenafil;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Yongfatt Vision Tr — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Pharmacy International, Inc.

**Import alert:** 66-57

**Import alert name:** "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."

**Country:** MALAYSIA

**Address:** Jln Bk 4/1l , Kuala Lumpur, Wilayah Persekutuan MALAYSIA

**Date published:** 09/10/2009

**Product code:** 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs

**Product:** All Prescription Drugs

**FDA notes:** 11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001 | All Prescription Drugs;11/25/2001

> Pharmacy International, Inc. Date Published : 09/10/2009 Jln Bk 4/1l , Kuala Lumpur, Wilayah Persekutuan MALAYSIA 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/05/2021 Desc: All Prescription Drugs Notes: 11/25/2001 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All Prescription Drugs;11/25/2001

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_197.html>

Pharmacy International, Inc. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Baja Fur S A De C V

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Romano 1352 , Tijuana, MEXICO

**Date published:** 02/02/2010

**Product code:** 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.

**Product:** ALl Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue) | All Eyelash Kits (With and without Glue)

**FDA notes:** 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 | 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

> Baja Fur S A De C V Date Published : 02/02/2010 Calle Romano 1352 , Tijuana, MEXICO 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) Date Published: 08/28/2010 Desc: ALl Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 53 C - - 99 Other Eye Makeup Preparations, N.E.C. Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/28/2010 Desc: All Eyelash Kits (With and without Glue) Notes: 601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Baja Fur S A De C V — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Christian Cosmetics

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Ensenada #394, Sec. Triangulo De , Tijuana, MEXICO

**Date published:** 06/18/2014

**Product code:** 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder | 53 C - - 03 Eye Shadow (Eye Makeup Preparations)

**Product:** Christian Eyebrow makeup Bronzed | Christian Eyebrow makeup Charcoal | Christian Eyebrow makeup black | Eyebrow Make Up Kits

**FDA notes:** 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 | 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 | 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 | 601(a); Organisms recovered include Gram negative Pseudomonas oryzihabitans; Gram negative Pantoea spp; Gram positive rods; Gram negative Sphingomonas paucimobilis; Gram positive; Micrococcus spp; Oxidase positive; non-lactose fermenting and Gram positive spore forming bacillus; Pseudomonas Stutzeri; Sphingomonas paucimobilis; S. epidermidis; S. hominis; S. warneri; Serratia fonticola; Yeast and Mold. Published on 05/21/2012

> Christian Cosmetics Date Published : 06/18/2014 Calle Ensenada #394, Sec. Triangulo De , Tijuana, MEXICO 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder Date Published: 06/18/2014 Desc: Christian Eyebrow makeup Bronzed Notes: 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder Date Published: 06/18/2014 Desc: Christian Eyebrow makeup Charcoal Notes: 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 53 C H - 03 Eye Shadow (Eye Makeup Preparations), Powder Date Published: 06/18/2014 Desc: Christian Eyebrow makeup black Notes: 601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus;5/23/2012 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 06/18/2014 Desc: Eyebrow Make Up Kits Notes: 601(a); Organisms recovered include Gram negative Pseudomonas oryzihabitans; Gram negative Pantoea spp; Gram positive rods; Gram negative Sphingomonas paucimobilis; Gram positive; Micrococcus spp; Oxidase positive; non-lactose fermenting and Gram positive spore forming bacillus; Pseudomonas Stutzeri; Sphingomonas paucimobilis; S. epidermidis; S. hominis; S. warneri; Serratia fonticola; Yeast and Mold. Published on 05/21/2012

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Christian Cosmetics — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Comercial Urania Sa De Cv

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Saltillo No 119 , Col. Hipodromo, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO

**Date published:** 05/29/2012

**Product code:** 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.

**Product:** Moisturizing Cream | Moisturizing Cream | Moisturizing Cream | Moisturizing Cream

**FDA notes:** B.Cepacian | B.Cepacian | B.Cepacian | B.Cepacian

> Comercial Urania Sa De Cv Date Published : 05/29/2012 Calle Saltillo No 119 , Col. Hipodromo, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 05/29/2012 Desc: Moisturizing Cream Notes: B.Cepacian 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) Date Published: 05/29/2012 Desc: Moisturizing Cream Notes: B.Cepacian 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/29/2012 Desc: Moisturizing Cream Notes: B.Cepacian 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 05/29/2012 Desc: Moisturizing Cream Notes: B.Cepacian

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Comercial Urania Sa De Cv — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Commercializadora Intergral Belleza Sa Cv

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Ticoman No14 Tepeyac Insurgentes , Mexico City, MEXICO

**Date published:** 04/20/2012

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations)

**Product:** Mascara with Avocado oil

**FDA notes:** 601(a) Enterococcus faecium

> Commercializadora Intergral Belleza Sa Cv Date Published : 04/20/2012 Calle Ticoman No14 Tepeyac Insurgentes , Mexico City, MEXICO 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 04/20/2012 Desc: Mascara with Avocado oil Notes: 601(a) Enterococcus faecium

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Commercializadora Intergral Belleza Sa Cv — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Cosmetobellezas Natural S.A De C.V.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Martin Luis Guzman 215 , Colonia Iztaccihuatl , Benito Juarez, Ciudad de Mexico MEXICO

**Date published:** 09/18/2009

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations)

**Product:** Mascara w/mamey seed oil;7/15/03

**FDA notes:** 601(a); gram negative rods

> Cosmetobellezas Natural S.A De C.V. Date Published : 09/18/2009 Calle Martin Luis Guzman 215 , Colonia Iztaccihuatl , Benito Juarez, Ciudad de Mexico MEXICO 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: Mascara w/mamey seed oil;7/15/03 Notes: 601(a); gram negative rods

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Cosmetobellezas Natural S.A De C.V. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Dermatisse Cosmeticos S.A. De C.V.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Avenida San Jeronimo 506-A , Col. TORRES DE SAN JERONIMO , Monterrey, Nuevo Leon MEXICO

**Date published:** 03/14/2011

**Product code:** 53 C - - 02 Eyeliner (Eye Makeup Preparations) | 53 C - - 03 Eye Shadow (Eye Makeup Preparations) | 53 G - - 05 Lipstick (Makeup Preparations, not for Eyes) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.

**Product:** Eyeshadow Compact Dermatisse Brand | Eyeshadow Compact Dermatisse Brand | Eyeshadow Compact Dermatisse Brand | Eyeshadow Compact Dermatisse Brand

**FDA notes:** 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens | 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

> Dermatisse Cosmeticos S.A. De C.V. Date Published : 03/14/2011 Avenida San Jeronimo 506-A , Col. TORRES DE SAN JERONIMO , Monterrey, Nuevo Leon MEXICO 53 C - - 02 Eyeliner (Eye Makeup Preparations) Date Published: 03/14/2011 Desc: Eyeshadow Compact Dermatisse Brand Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens 53 C - - 03 Eye Shadow (Eye Makeup Preparations) Date Published: 03/14/2011 Desc: Eyeshadow Compact Dermatisse Brand Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens 53 G - - 05 Lipstick (Makeup Preparations, not for Eyes) Date Published: 03/14/2011 Desc: Eyeshadow Compact Dermatisse Brand Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 03/14/2011 Desc: Eyeshadow Compact Dermatisse Brand Notes: 601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Dermatisse Cosmeticos S.A. De C.V. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Framesi Laboratorios, S.A. de C.V.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Miguel Cruz Afdo., No. 10-B , Col. Flores Magon , Mexico, D.F. MEXICO

**Date published:** 09/18/2009

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 C - - 06 Mascara (Eye Makeup Preparations)

**Product:** Mascara with mamey seed oil; 9/4/03 | Mascara w/avocado oil; 5/5/04

**FDA notes:** 601(c); multiple micro contaminants & non-fermentative gram negative rods and gram positive rods with spores | ENTEROBACTER : CLOACAE; | 601(a) | ENTEROBACTER : CLOACAE; PSEUDOMONAS : AERUGINOSA; LECLERCIA : ADECARBOXYLATA; KLEBSIELLA : PNEUMONIAE;

> Framesi Laboratorios, S.A. de C.V. Date Published : 09/18/2009 Miguel Cruz Afdo., No. 10-B , Col. Flores Magon , Mexico, D.F. MEXICO 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: Mascara with mamey seed oil; 9/4/03 Notes: 601(c); multiple micro contaminants & non-fermentative gram negative rods and gram positive rods with spores Problems: ENTEROBACTER : CLOACAE; 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: Mascara w/avocado oil; 5/5/04 Notes: 601(a) Problems: ENTEROBACTER : CLOACAE; PSEUDOMONAS : AERUGINOSA; LECLERCIA : ADECARBOXYLATA; KLEBSIELLA : PNEUMONIAE;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Framesi Laboratorios, S.A. de C.V. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Industrializadora de Cacahuananche, S.A. de C.V.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Camino Arenero No. 20 , Col. San Juan De Ocotan, Zapopan , Zapopan, Jalisco MEXICO

**Date published:** 10/12/2017

**Product code:** 53 E - - 06 Shampoos (Hair Preparations, Non-coloring)

**Product:** Shampoo Herbal Bear Oil Aceite de Oso

**FDA notes:** Problem(s); Pseudomonas Aeruginosa

> Industrializadora de Cacahuananche, S.A. de C.V. Date Published : 10/12/2017 Calle Camino Arenero No. 20 , Col. San Juan De Ocotan, Zapopan , Zapopan, Jalisco MEXICO 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 10/12/2017 Desc: Shampoo Herbal Bear Oil Aceite de Oso Notes: Problem(s); Pseudomonas Aeruginosa

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Industrializadora de Cacahuananche, S.A. de C.V. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Laboratorios Naturamex

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Morelos Sur 899 , Col. Ventura Puente , Morelia, Michoacan MEXICO

**Date published:** 09/18/2009

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations)

**Product:** Avocado seed oil & mamey seed oil; 3/25/04

**FDA notes:** multiple micro contaminants including yeast/mold; gram positive rods; gram negative rods | STAPHYLOCOCCUS; CHRYSEOMONAS : LUTEOLA;

> Laboratorios Naturamex Date Published : 09/18/2009 Calle Morelos Sur 899 , Col. Ventura Puente , Morelia, Michoacan MEXICO 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: Avocado seed oil & mamey seed oil; 3/25/04 Notes: multiple micro contaminants including yeast/mold; gram positive rods; gram negative rods Problems: STAPHYLOCOCCUS; CHRYSEOMONAS : LUTEOLA;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Laboratorios Naturamex — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** MEGAMIX

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Antonio Alzate #71 Int. "A" Centro , Morelia, MEXICO

**Date published:** 09/18/2009

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)

**Product:** Mascara

**FDA notes:** Mascara; 5/10/05 | Mascara;5/10/05 | 5/10/05

> MEGAMIX Date Published : 09/18/2009 Calle Antonio Alzate #71 Int. "A" Centro , Morelia, MEXICO 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Notes: Mascara; 5/10/05 53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations) Date Published: 09/18/2009 Notes: Mascara;5/10/05 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) Date Published: 03/30/2021 Desc: Mascara Notes: 5/10/05

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

MEGAMIX — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** NATRA BAY SA DE CV

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Benito Juarez S/N Loc 2 Ent. Cjon , Col. CENTRO , Loreto, Baja California sur MEXICO

**Date published:** 12/02/2013

**Product code:** 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations)

**Product:** Moringa Oil | Powdered Moringa Root

**FDA notes:** Charge -- Yeast/mold | Charge -- Kleibseilla pneumonia

> NATRA BAY SA DE CV Date Published : 12/02/2013 Benito Juarez S/N Loc 2 Ent. Cjon , Col. CENTRO , Loreto, Baja California sur MEXICO 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 12/02/2013 Desc: Moringa Oil Notes: Charge -- Yeast/mold 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 12/02/2013 Desc: Powdered Moringa Root Notes: Charge -- Kleibseilla pneumonia

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

NATRA BAY SA DE CV — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Probelco S.A. de D.V.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Biznaga No. 43 , Col. Las Palmas, Alvaro Obregon , Ciudad De Mexico, Ciudad de Mexico MEXICO

**Date published:** 09/18/2009

**Product code:** 53 C - - 02 Eyeliner (Eye Makeup Preparations)

**Product:** 7/25/08

**FDA notes:** 601(a) | PSEUDOMONAS : PUTIDA;

> Probelco S.A. de D.V. Date Published : 09/18/2009 Calle Biznaga No. 43 , Col. Las Palmas, Alvaro Obregon , Ciudad De Mexico, Ciudad de Mexico MEXICO 53 C - - 02 Eyeliner (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: 7/25/08 Notes: 601(a) Problems: PSEUDOMONAS : PUTIDA;

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Probelco S.A. de D.V. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Prosa Productos Naturales, S.A. de C.V.

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** 4a Cerrada Sur 57 174 , Mexico, DF MEXICO

**Date published:** 09/18/2009

**Product code:** 53 C - - 06 Mascara (Eye Makeup Preparations)

**Product:** Mascara w/mamey seed oil;9/23/03

**FDA notes:** 601(a); gram positive and gram negative bacilli

> Prosa Productos Naturales, S.A. de C.V. Date Published : 09/18/2009 4a Cerrada Sur 57 174 , Mexico, DF MEXICO 53 C - - 06 Mascara (Eye Makeup Preparations) Date Published: 09/18/2009 Desc: Mascara w/mamey seed oil;9/23/03 Notes: 601(a); gram positive and gram negative bacilli

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

Prosa Productos Naturales, S.A. de C.V. — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** REJUVENTUM, SA DE CV

**Import alert:** 53-17

**Import alert name:** "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

**Country:** MEXICO

**Address:** Calle Zaragoza No 1 , Colonia Cuajimalpa , Cuajimalpa De Morelos, Ciudad de Mexico MEXICO

**Date published:** 12/17/2013

**Product code:** 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)

**Product:** Hydrating Toner

**FDA notes:** CHARGE/CONTAMINANT -- 601(a); B. vallisomortis and E. gergoviae

> REJUVENTUM, SA DE CV Date Published : 12/17/2013 Calle Zaragoza No 1 , Colonia Cuajimalpa , Cuajimalpa De Morelos, Ciudad de Mexico MEXICO 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/17/2013 Desc: Hydrating Toner Notes: CHARGE/CONTAMINANT -- 601(a); B. vallisomortis and E. gergoviae

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_136.html>

REJUVENTUM, SA DE CV — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** ASESORIA Y DESARROLLO DE PRODUCTOS NATURALES

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MEXICO

**Address:** Avenida Mexico #3300 D-14, Monraz , Jalisco , Guadalajara, MEXICO

**Date published:** 07/29/2024

**Product code:** 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs

**Product:** UMARY Acido Hialuronico | UMARY Acido Hialuronico | UMARY Acido Hialuronico

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole.

> ASESORIA Y DESARROLLO DE PRODUCTOS NATURALES Date Published : 07/29/2024 Avenida Mexico #3300 D-14, Monraz , Jalisco , Guadalajara, MEXICO 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 07/29/2024 Desc: UMARY Acido Hialuronico Notes: FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 46 Y - - 99 Food Additives For Human Use, N.E.C. Date Published: 07/29/2024 Desc: UMARY Acido Hialuronico Notes: FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/29/2024 Desc: UMARY Acido Hialuronico Notes: FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 56 - - - -- Antibiotics (Human/Animal) Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 60 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 61 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 62 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 63 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 64 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 65 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 66 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole.

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

ASESORIA Y DESARROLLO DE PRODUCTOS NATURALES — FDA import alert red lists: firms subject to detention without physical examination


**Firm:** Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.

**Import alert:** 54-16

**Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"

**Country:** MEXICO

**Address:** Avenida Patria 288-1 , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO

**Date published:** 07/29/2024

**Product code:** 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs

**Product:** UMARY Acido Hialuronico | UMARY Acido Hialuronico | UMARY Acido Hialuronico

**FDA notes:** FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole | UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole

> Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V. Date Published : 07/29/2024 Avenida Patria 288-1 , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 07/29/2024 Desc: UMARY Acido Hialuronico Notes: FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 46 Y - - 99 Food Additives For Human Use, N.E.C. Date Published: 07/29/2024 Desc: UMARY Acido Hialuronico Notes: FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/29/2024 Desc: UMARY Acido Hialuronico Notes: FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 56 - - - -- Antibiotics (Human/Animal) Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 60 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 61 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 62 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 63 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 64 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 65 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole 66 - - - -- Human and Animal Drugs Date Published: 07/29/2024 Notes: UMARY Acido Hialuronico; FDA laboratory analysis confirmed product contains undeclared diclofenac and omeprazole

Source: <https://www.accessdata.fda.gov/cms_ia/importalert_1141.html>

Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V. — FDA import alert red lists: firms subject to detention without physical examination