The Food and Drug Administration (FDA) warned the public against the purchase and use of 17 unregistered drug products, citing potential health risks.
In an advisory on Monday, May 6, FDA said the unregistered products include, “Recombinant Human Erythropoietin Injection IP 4000 IU (Renocrit 4000), a single-dose pre-filled syringe containing 4000 IU/ 0.4 mL,” “OTC JUCISHAN Sodium Cromoglicate Eye Drops,” “GUANG HUI Compound Ketoconazole Cream,” “Chlorzoxazone 0.29 Tablet,” “JUCISHAN Dexamethasone Sodium Phosphate Injection 1 mL 5 mg Ampoule,” “NANZ i-Drops 15mL,” “OTC Metronidazole and Chlorhexidine Lotion,” “OTC GOLDEN SUN Clindamycin Hydrochloride Gel,” “MING TAI YI Badu Gao,” “Haima Baji Jiaonang,” “OTC Loratadine Tablets,” “OTC Topfond Luleitading Pian Loratadine Tablets,” “Lihua Bidouyan Pian,” “MINSHENG Tobramycin and Dexamethasone Eye Drops 5mL,” “TRT Pharma Pifubing Xuedu Wan,” “Dawnrays Levocetirizine Dihydrochloride Tablets 5mg,” and “OTC Erythromycin Ointment 5g.”
Based on the FDA's Post-Marketing Surveillance (PMS) activities, these drugs have not undergone the necessary registration process nor received proper authorization in the form of a Certificate of Product Registration.
With this, the FDA cannot guarantee its quality, safety, and efficacy, raising concerns about potential health hazards associated with its usage.
The agency also noted that under Republic Act No. 9711, also known as the “Food and Drug Administration Act of 2009,” the manufacture, importation, exportation, sale, distribution, promotion, advertising, or sponsorship of health products without proper authorization from the FDA is strictly prohibited.
It cautioned all establishments involved not to distribute the aforementioned violative drug product until it receives the appropriate authorization.
Failure to comply may result in regulatory actions and sanctions, the FDA said.
Moreover, local government units and law enforcement agencies (LEAs) have been called upon to ensure that this product is not sold or made available within their respective jurisdictions.