DULAC FARMACEUTICI 1982 SRL · 66-41 · ITALY
For DULAC FARMACEUTICI 1982 SRL · 66-41 · ITALY, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is ITALY; product is Diosmin Expert Omniven 500 | Diosmin Expert Procto Complex Hemorrhoid Cream | Diosmin Expert Omniven Gambe | Diosmin Expert Omniven 500 | Diosmin Expert Omniven 500 Tablets | Diosmin Expert Omniven Gambe | Diosmin Expert Omniven 500 | Diosmin Expert Procto Complex Hemorrhoid Cream | Diosmin Expert Omniven 500 Tablets | Diosmin Expert Procto Complex Hemorrhoid Cream | Diosmin Expert Omniven 500 Tablets; product code is 45 C - - 99 Antioxidants (Food Additives for Human Use) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), 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 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 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 05/21/2024; address is Via San Quintino 28 , Turin, ITALY, verified against its source on 2026-09-16.
- Firm
- DULAC FARMACEUTICI 1982 SRL verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- ITALY verified
- Address
- Via San Quintino 28 , Turin, ITALY verified
- Date published
- 05/21/2024 verified
- Product code
- 45 C - - 99 Antioxidants (Food Additives for Human Use) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), 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 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 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Diosmin Expert Omniven 500 | Diosmin Expert Procto Complex Hemorrhoid Cream | Diosmin Expert Omniven Gambe | Diosmin Expert Omniven 500 | Diosmin Expert Omniven 500 Tablets | Diosmin Expert Omniven Gambe | Diosmin Expert Omniven 500 | Diosmin Expert Procto Complex Hemorrhoid Cream | Diosmin Expert Omniven 500 Tablets | Diosmin Expert Procto Complex Hemorrhoid Cream | Diosmin Expert Omniven 500 Tablets each item verified
- FDA notes
- The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its label and labeling includes claims such as: “DIOSMIN EXPERT PROCTO COMPLEX with Diosmin…is an ointment that helps alleviate the most common complaints associated with hemorrhoids. This complex of active principles has been purposely developed to alleviate the typical itching and pain caused by hemorrhoids and fissures.”, “Cream for hemorrhoids without cortisone” , “Procto Complex, our haemorroids [sic] cream, will quickly become your ally” and “Procto Complex is rich in Hypericum, Centella asiatica, Diosmin, Escin and Horse Chestnut, which promote microcirculation function and improve venous and capillary tone.” | The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its labels includes claims such as: “Butcher’s Broom [an ingredient in the products] also contributes to the correct functioning of the venous circulation at the level of the haemorrhoidal [sic] plexus.”, and firm’ website includes claims such as: “Helps in case of hemorrhoids”, “Relief from heavy and swollen legs”, “Support against varicose veins and fragile capillaries”, “Are you looking for valid support against hemorrhoids, swollen and heavy legs, fragile capillaries, varicose veins and all the discomfort caused by bad microcirculation?”, “Omniven 500 is aimed at all people who suffer from poor microcirculation function. This problem manifests itself in numerous was, including internal or external hemorrhoids, heaviness and swelling of the legs, varicose veins, fragile capillaries (the so-called broken capillaries on the legs)….” and “Horse Chestnut (6 mg) Its protective action on the microcirculation is achieved in particular in the reduction of the permeability and fragility of the capillaries, but also in the improvement of lymphatic drainage….”. | The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its label and labeling includes claims such as: “DIOSMIN EXPERT PROCTO COMPLEX with Diosmin…is an ointment that helps alleviate the most common complaints associated with hemorrhoids. This complex of active principles has been purposely developed to alleviate the typical itching and pain caused by hemorrhoids and fissures.”, “Cream for hemorrhoids without cortisone” , “Procto Complex, our haemorroids [sic] cream, will quickly become your ally” and “Procto Complex is rich in Hypericum, Centella asiatica, Diosmin, Escin and Horse Chestnut, which promote microcirculation function and improve venous and capillary tone.” | The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its labels includes claims such as: “Butcher’s Broom [an ingredient in the products] also contributes to the correct functioning of the venous circulation at the level of the haemorrhoidal [sic] plexus.”, and firm’ website includes claims such as: “Helps in case of hemorrhoids”, “Relief from heavy and swollen legs”, “Support against varicose veins and fragile capillaries”, “Are you looking for valid support against hemorrhoids, swollen and heavy legs, fragile capillaries, varicose veins and all the discomfort caused by bad microcirculation?”, “Omniven 500 is aimed at all people who suffer from poor microcirculation function. This problem manifests itself in numerous was, including internal or external hemorrhoids, heaviness and swelling of the legs, varicose veins, fragile capillaries (the so-called broken capillaries on the legs)….” and “Horse Chestnut (6 mg) Its protective action on the microcirculation is achieved in particular in the reduction of the permeability and fragility of the capillaries, but also in the improvement of lymphatic drainage….”. | The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its label and labeling includes claims such as: “DIOSMIN EXPERT PROCTO COMPLEX with Diosmin…is an ointment that helps alleviate the most common complaints associated with hemorrhoids. This complex of active principles has been purposely developed to alleviate the typical itching and pain caused by hemorrhoids and fissures.”, “Cream for hemorrhoids without cortisone” , “Procto Complex, our haemorroids [sic] cream, will quickly become your ally” and “Procto Complex is rich in Hypericum, Centella asiatica, Diosmin, Escin and Horse Chestnut, which promote microcirculation function and improve venous and capillary tone.” | The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its labels includes claims such as: “Butcher’s Broom [an ingredient in the products] also contributes to the correct functioning of the venous circulation at the level of the haemorrhoidal [sic] plexus.”, and firm’ website includes claims such as: “Helps in case of hemorrhoids”, “Relief from heavy and swollen legs”, “Support against varicose veins and fragile capillaries”, “Are you looking for valid support against hemorrhoids, swollen and heavy legs, fragile capillaries, varicose veins and all the discomfort caused by bad microcirculation?”, “Omniven 500 is aimed at all people who suffer from poor microcirculation function. This problem manifests itself in numerous was, including internal or external hemorrhoids, heaviness and swelling of the legs, varicose veins, fragile capillaries (the so-called broken capillaries on the legs)….” and “Horse Chestnut (6 mg) Its protective action on the microcirculation is achieved in particular in the reduction of the permeability and fragility of the capillaries, but also in the improvement of lymphatic drainage….”. each item verified
What the source says
DULAC FARMACEUTICI 1982 SRL Date Published : 05/21/2024 Via San Quintino 28 , Turin, ITALY 45 C - - 99 Antioxidants (Food Additives for Human Use) Date Published: 09/17/2024 Desc: Diosmin Expert Omniven 500 Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/21/2024 Desc: Diosmin Expert Procto Complex Hemorrhoid Cream Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its label and labeling includes claims such as: “DIOSMIN EXPERT PROCTO COMPLEX with Diosmin…is an ointment that helps alleviate the most common complaints associated with hemorrhoids. This complex of active principles has been purposely developed to alleviate the typical itching and pain caused by hemorrhoids and fissures.”, “Cream for hemorrhoids without cortisone” , “Procto Complex, our haemorroids [sic] cream, will quickly become your ally” and “Procto Complex is rich in Hypericum, Centella asiatica, Diosmin, Escin and Horse Chestnut, which promote microcirculation function and improve venous and capillary tone.” 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/20/2024 Desc: Diosmin Expert Omniven Gambe Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/17/2024 Desc: Diosmin Expert Omniven 500 Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/21/2024 Desc: Diosmin Expert Omniven 500 Tablets Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its labels includes claims such as: “Butcher’s Broom [an ingredient in the products] also contributes to the correct functioning of the venous circulation at the level of the haemorrhoidal [sic] plexus.”, and firm’ website includes claims such as: “Helps in case of hemorrhoids”, “Relief from heavy and swollen legs”, “Support against varicose veins and fragile capillaries”, “Are you looking for valid support against hemorrhoids, swollen and heavy legs, fragile capillaries, varicose veins and all the discomfort caused by bad microcirculation?”, “Omniven 500 is aimed at all people who suffer from poor microcirculation function. This problem manifests itself in numerous was, including internal or external hemorrhoids, heaviness and swelling of the legs, varicose veins, fragile capillaries (the so-called broken capillaries on the legs)….” and “Horse Chestnut (6 mg) Its protective action on the microcirculation is achieved in particular in the reduction of the permeability and fragility of the capillaries, but also in the improvement of lymphatic drainage….”. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/20/2024 Desc: Diosmin Expert Omniven Gambe Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/17/2024 Desc: Diosmin Expert Omniven 500 Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/21/2024 Desc: Diosmin Expert Procto Complex Hemorrhoid Cream Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its label and labeling includes claims such as: “DIOSMIN EXPERT PROCTO COMPLEX with Diosmin…is an ointment that helps alleviate the most common complaints associated with hemorrhoids. This complex of active principles has been purposely developed to alleviate the typical itching and pain caused by hemorrhoids and fissures.”, “Cream for hemorrhoids without cortisone” , “Procto Complex, our haemorroids [sic] cream, will quickly become your ally” and “Procto Complex is rich in Hypericum, Centella asiatica, Diosmin, Escin and Horse Chestnut, which promote microcirculation function and improve venous and capillary tone.” 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/21/2024 Desc: Diosmin Expert Omniven 500 Tablets Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its labels includes claims such as: “Butcher’s Broom [an ingredient in the products] also contributes to the correct functioning of the venous circulation at the level of the haemorrhoidal [sic] plexus.”, and firm’ website includes claims such as: “Helps in case of hemorrhoids”, “Relief from heavy and swollen legs”, “Support against varicose veins and fragile capillaries”, “Are you looking for valid support against hemorrhoids, swollen and heavy legs, fragile capillaries, varicose veins and all the discomfort caused by bad microcirculation?”, “Omniven 500 is aimed at all people who suffer from poor microcirculation function. This problem manifests itself in numerous was, including internal or external hemorrhoids, heaviness and swelling of the legs, varicose veins, fragile capillaries (the so-called broken capillaries on the legs)….” and “Horse Chestnut (6 mg) Its protective action on the microcirculation is achieved in particular in the reduction of the permeability and fragility of the capillaries, but also in the improvement of lymphatic drainage….”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/21/2024 Desc: Diosmin Expert Procto Complex Hemorrhoid Cream Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its label and labeling includes claims such as: “DIOSMIN EXPERT PROCTO COMPLEX with Diosmin…is an ointment that helps alleviate the most common complaints associated with hemorrhoids. This complex of active principles has been purposely developed to alleviate the typical itching and pain caused by hemorrhoids and fissures.”, “Cream for hemorrhoids without cortisone” , “Procto Complex, our haemorroids [sic] cream, will quickly become your ally” and “Procto Complex is rich in Hypericum, Centella asiatica, Diosmin, Escin and Horse Chestnut, which promote microcirculation function and improve venous and capillary tone.” 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/21/2024 Desc: Diosmin Expert Omniven 500 Tablets Notes: The product appears to be a new drug within the meaning of Section 201(p) of the Act, without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)], as its labels includes claims such as: “Butcher’s Broom [an ingredient in the products] also contributes to the correct functioning of the venous circulation at the level of the haemorrhoidal [sic] plexus.”, and firm’ website includes claims such as: “Helps in case of hemorrhoids”, “Relief from heavy and swollen legs”, “Support against varicose veins and fragile capillaries”, “Are you looking for valid support against hemorrhoids, swollen and heavy legs, fragile capillaries, varicose veins and all the discomfort caused by bad microcirculation?”, “Omniven 500 is aimed at all people who suffer from poor microcirculation function. This problem manifests itself in numerous was, including internal or external hemorrhoids, heaviness and swelling of the legs, varicose veins, fragile capillaries (the so-called broken capillaries on the legs)….” and “Horse Chestnut (6 mg) Its protective action on the microcirculation is achieved in particular in the reduction of the permeability and fragility of the capillaries, but also in the improvement of lymphatic drainage….”.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.