Pharmaceutical Advisories

FDA Advisory No. 2017-285-A

Public Health Warning Against the Purchase and Use of the Unregistered Veterinary Drug Product Tocopheryl Acetate + Ginseng + Methyltestosterone 100 mg/ 10 mg/ 7.5 mg (Red Gel Forte) Softgel Capsule

 

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered veterinary drug product Tocopheryl Acetate + Ginseng + Methyltestosterone 100 mg/ 10 mg/ 7.5 mg (Red Gel Forte) Softgel Capsule, with Registration No. VR-2824, imported/distributed by Lakpue Drug, Inc.


As per FDA Database, the validity of the Certificate of Product Registration (CPR) of the said product has expired last 19 March 2017, and no renewal registration application has been filed since then.
Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.


In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against drug products that might not be duly registered with the FDA. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.


All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.


For more information and inquiries, please e-mail us at This email address is being protected from spambots. You need JavaScript enabled to view it.. To report continuous sale or distribution of unregistered health products, kindly e-mail us via This email address is being protected from spambots. You need JavaScript enabled to view it., or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

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