# BIO-GULF SDN BHD · 66-41 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** MALAYSIA _(verified: appears in the quote below)_
- **Address:** Plaza Damansara , 24 2 Jalan , Kuala Lumpur, Wilayah Persekutuan MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **Product:** Libidus | Libidus | Libidus _(also on this page, in the second passage quoted below)_

## 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.

## 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).