FDA Advisory No. 2018-113
Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:
- Glutax® 8000GZ Mirco Pro S-Acetyl
- Glutax® 23000GK DNA Glutokines
- Glutax® 5GS Plus Micro EGF Advance Cellular Ultra Whitening Plus Firming New Formulation
- Glutax® 6GS Platina Gold Advance 2 x Excellent Resistance to Sunburn
- Glutax® 75GS Nano Pro Cell
- Glutax® 5000GF Micro 5000 Forte
- L-Carn® 5g Wirkstoff: L-Carnitin 50 Ampullen zu 5ml (N1)
- Sterile Water for Injection (LTN Sterile Water for Injection) 5 mL
- Piam Rition 5000mg polvere per soluzione per infusione glutatione Medicinale equivalente
- Reduced Glutathione for Injection
- Vitamin BC 2mL Solution for Injection
- Reduced Glutathione (Salutamax 600mg Reduced Glutathione)
- Kosdaq Cindella Inj. I.V. (Thioctic acid 25mg/5mL) Solution for Injection
- Laroscorbine Platinum® XL-10 10 mL Solution Injectable I.V.
- Aqua SkinTM EGF Whitening Pro-Q10 RNA Complex Micromolecule Pro-Coenzyme Q10 with Ribonucleic Acid Pure Gold
- Glutax® 5g Glutathione 5000mg Cellular Ultra Whitening
- Nano Refine Kojic Acid Whitening and Hydrating 40000 Japan
- Kosdaq DHNP S.C./I.M./I.V. Vitamin C Inj. Ascorbic acid 10g/20mL
- Estrediol Valerate Injection USP Progynon® Depot 10 mg/ml Solution for Injection
- Lidocaine • Prilocaine Local anesthetics J-Pro Cream Lidocaine 25mg + Prilocaine 25mg
- unlabeled capsules (size 0)
- unlabeled capsules (size 00)
- Glutax 24K Numeric
- Neutro Skin Pomegranate Whitening + Antioxidant
- MW Miracle White
- Liposolves PPS – Phosphatidycholine 500mg Levo Carnitine 2500mg Solution for Injection
- Kosdaq I.M./I.V. Infusion Luthione Inj. 1200 mg Powder for Injection
- Glutax® 5GS Micro Advance Cellular Ultra Skin Whitening + Anti Aging
- Glutax® 70000GM Marine White Optimum
- Biocell 5000 Plus 5 mL Solution for Injection
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
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 Certificates 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 their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.
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 they 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.