FDA Advisory No. 2017-192
Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:
- Tationil Plus 1500
- Beauoxi White plus 1200
- Tationil 600 mg / 4 mL
- Advanced Glutathione Rex Pharma 3 g
- V-C Injection
- GSH DermaForte 1500
- Placenta Lucchini Fresh Cell Therapy
- Thionemax 900
- Laennec Inj. Placenta Extract (Human)
- GSH Lumineux 1200
- Tioredox 4.8 g
- Advanced Glutathione Rex Pharma 2,400 mg
- GSH Ultima 1500
- Reduced Glutathione (Saluta) 600 mg/Vial Powder for Injection IM/IV
- Reduced Glutathione / Hydrolyzed Collagen, 1200 mg / 200 mg Vial Powder for Injection (Lyophilized Powder) (Tatiomax)
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products.
Food and Drug Administration (FDA) post-marketing surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the agency and have not been issued with proper authorization in the form of Certificate of Product Registration.
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.
Accordingly, since these unregistered drug products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The use of such violative products may pose potential health hazards to the consuming public.
In light of the above, the public is advised not to purchase the aforementioned violative products 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 products until it have 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 these products are not sold or made available in their localities or areas of jurisdiction.
Dissemination of the information to all concerned is requested.