The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- Chloramphenicol Eye Drops Eye Sight 8ml:20mg
- Levofloxacin Hydrochloride Tablets 0.1g
- OTC Sucralfate Chewable Tablets
- Folic Acid Tablets 5mg
- SINE® Calcium Gluconate Injection 10ml:1g
- HUAYI® Vitamin C Injection 2ml:0.5g
- WY® Metronidazole Tablets 0.2 g
- Sodium Chloride Injection 0.9% 100 ml
- Glucose Injection 5% 100 ml
- QIANGSHEN®Amikacin Sulfate Injection 2ml:0.2g
- TS® Ribavirin Injection 1ml:0.1g
- Micronomicin Sulfate Injection 2ml:60mg
- Jucishan® Ribavirin Injection 1ml:100mg
- Oxytocin Injection 1ml:10
- Ceftriaxone Sodium for Injection 1.0g
- Lysine Acetylsalicylate for Injection 0.9g
- Potassium Sodium Dehydroandrographolide Succinate for Injection – Zhusheyong Yanhuning 80 mg
- Progesterone Injection 1ml :20mg
- OTC Jinsangzi Houpian [as reflected in the primary packaging] OTC Golden Throat Lozenge [as reflected in the secondary packaging]
- Ornidazole and Sodium Chloride Injection 100 ml
- Azithromycin for Injection 0.25 g
- Azithromycin Dispersible Tablets 6’s
- Wing Long Red Flower Oil
- OTC Ibuprofen Sustained Release Capsule
- JUCISHAN® Ofloxacin Eye Drops 5ml:15mg
- Doxycycline Hyclate Tablets
- yatai® Aciclovir Tablets 0.1 g
- Imodium® 2mg
- SPH Furazolidone Tablets
- Metronidazole and Sodium Chloride Injection 100 ml
- Methylrosanilinium Chloride Solution
- Merbromin Solution
- Fat Emulsion Injection 20% 250 ml
- OTC Anti-Hemorrhoids Suppository
- Compound Aminophenazone and Barbital Injection 2ml
- Compound Amionpyrine and Antipyrine Injection 2ml
- Raceanisodamine Hydrochloride Injection 1ml
FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. 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.who-umc.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.2020-1434