The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- Sanglianpai® Sai wei’an Jiaonang
- Clindamycin Phosphate Injection 2ml : 0.3g [as reflected in the secondary packaging]
- Vitamin B6 Injection 2ml : 0.1g
- Viaminate Capsules
- OTC Bausch + Lomb
- Compound Miconazole Nitrate Cream
- OTC Cyproheptadine Hydrochloride Cream
- Triamcinolone Acetonide Nasal Spray
- OTC Fufang Zaoren Jiaonang [as reflected in the package insert]
- Dexamethasone Acetate Cream 10g
- OTC Clotrimazole Cream [as reflected in the secondary packaging]
OTC Kemeizuo Rugao [as reflected in the primary packaging]
- OTC Compound Paracetamol and Amantadine Hydrochloride Tablets
- OTC Paracetamol, Caffein, Atificial Cow-bezoar and Chlorphenamine Maleate Capsules [as reflected in the package insert]
- Dexamethasone Acetate Oral Mucoadhesive Patches [as reflected in the package insert]
- OTC Shibiao Yaoye
- OTC Qing Yuan Calcium Gluconate Tablets
- OTC [Label in Foreign Language]
- Sine® Pipemidic Acid Tablets 0.25g
- SPH H31020387 [Label in Foreign Language] 0.4g x 80mg
- OTC Multienzyme Tablets
- H21022500 [Label in Foreign Language] 25mg
- Phenolphthalein Tablets 100mg
- Hydrochlorothiazide Tablets
- Dexamethasone Acetate Tablets 0.75mg
- Nimodipine Tablets 20mg
- Griseofulvin Tablets 0.1g
- OTC Sanhuangpian
- H33022029 [Label in Foreign Language]
- H51023736 [Label in Foreign Language] 50mg
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. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.
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.
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.
For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.whoumc.org/Reporting/Reporter? OrganizationID=PH and fill out all the required fields.
Dissemination of the information to all concerned is requested.
Attachment:-> FDA Advisory No.2020-1271