Reference Source

BIO-GULF SDN BHD · 66-41 · MALAYSIA

For BIO-GULF SDN BHD · 66-41 · MALAYSIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is MALAYSIA; product code is 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. | 65 P - - 02 Sildenafil Citrate (Regulator); date published is 09/30/2009; address is Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA, verified against its source on 2026-09-16.

Firm
BIO-GULF SDN BHD verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
MALAYSIA verified
Address
Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA verified
Date published
09/30/2009 verified
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. | 65 P - - 02 Sildenafil Citrate (Regulator) each item verified
FDA notes
Libidus is promoted on the websites and as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown. | Libidus is promoted on the websites and as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown. | Libidus is promoted on the websites and as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown. each item verified
Product
Libidus | Libidus | Libidus also on this page
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

BIO-GULF SDN BHD Date Published : 09/30/2009 Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/30/2009 Notes: Libidus is promoted on the websites and as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/30/2009 Notes: Libidus is promoted on the websites and as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown. 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 09/30/2009 Notes: Libidus is promoted on the websites and as an herbal male sexual stimulant and has been imported into the US as a dietary supplement. Analysis provided by CDERS Division of Pharmaceutical Analysis HFS-920 found that the capsules contain the undeclared chemical "acetildenafil," an analog of sildenafil. Sildenafil citrate is the active ingrediant in Viagras product manufactured by Pfizer for the treatment of erectile dysfunction. Acetildenafil is not declared as one of the ingrediants as one of the ingrediants on the Libidus' product lables and the pharmacology of this new drug is unknown.

accessdata.fda.gov, retrieved 2026-09-15

The same source also states

BIO-GULF SDN BHD Date Published : 09/13/2019 Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/13/2019 Desc: Libidus Notes: 6/29/2006 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/13/2019 Desc: Libidus Notes: 6/29/2006 65 P - - 02 Sildenafil Citrate (Regulator) Date Published: 09/13/2019 Desc: Libidus Notes: 6/29/2006

accessdata.fda.gov, retrieved 2026-09-15

Source

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