FDA warns public against use of 22 unregistered medicines


Posted at Mar 22 2015 06:42 PM | Updated as of Mar 23 2015 02:42 AM

MANILA - The Food and Drug Administration (FDA) has advised the public against the use of 22 medicines, which remain unregistered and are thus not proven to be safe for consumption.

In an advisory dated February 20, the FDA also ordered field officers to confiscate the products already in the market. “All local government units and law enforcement agencies are requested to ensure that these products are not sold or offered for sale in their localities or area of jurisdiction.”

The products are:

Bisacodyl (Delax) 5 mg Tablet
Conjugated Estrogens USP ( Conjugase-0.625) 0.625 mg Tablet
Bicalutamide 50 mg Tablet
Isosorbide dinitrate (Hartsorb Sublingual) 5 mg Tablet
Flunarazine (Sobelin) 5 mg Capsule
Loratadine (Clatidyne) 10 mg Tablet
Diclofenac Sodium + Misoprostol (Arthrotec 50) 50 mg/ 200 mcg Tablet
Cetirizine.2HCl (Cetrizin) 10 mg Tablet
Clindamycin (Clindacap-300) 300 mg Tablet
Simvastatin (Zimmex 20) 20 mg Tablet
Rosiglitazone maleate (Avandia) 4 mg Tablet
Gentamicin sulfate (Gentaderm) 0.1 g/ 100 g Cream
Nystatin (Tystatin) Oral Suspension
Dexamethasone Sodium Phosphate + Neomycin Sulfate (Archidex) Eye-Ear Drops
Omeprazole (Omeprazole GPO) 20 mg Capsule
Roxithromycin (Roxthrin) 150mg Tablet
Lansoprazole 30 mg Delayed-Release Capsule
Ketoconazole (Ninazol) 200 mg Tablet
Paracetamol (SaRa) 500 mg Tablet
Amoxicillin + Clavulanate Potassium 400 mg/ 57 mg per 5 mL Oral Suspension
Cefuroxime Axetil (Cefuroxime) 250 mg/ 5 mL Oral Suspension
Cefdinir 250 mg/ 5 mL Oral Suspension

The FDA warned drug establishments of importing, distributing, and selling the products, adding that the acts are subject to sanctions under the Food and Drug Administration Act and the Special Law on Counterfeit Drugs.

“All consumers are advised to purchase their medications only from FDA-licensed establishments. Please note that product evaluation and registration is a measure that the government undertakes to ensure the safety and efficacy of health products,” the FDA said.