FDA issues warning against purchase, use of 'unregistered' products
The Food and Drug Administration (FDA) has issued a warning to the public regarding the purchase and use of 10 unregistered products that have not undergone its evaluation process.
As of Aug. 23, the FDA has identified six devices and four drugs that are not considered safe.
The FDA has also alerted healthcare professionals and the general public not to buy or consume these unregistered products for their safety.
Unregistered drug products include “OTC Natural Green Leaf Skin Quick Clear Antifungal Cream 8g,” “Gongliuning Jiaonang 0.45g,” and “Aroma A Moringa 30 ml.”
The FDA's Post-Marketing Surveillance (PMS) operations confirmed that these drug products did not go through the agency's registration process and lacked the required authorization in the form of a Certificate of Product Registration (CPR).
Consuming these illegal products could pose health risks, as the FDA cannot guarantee their quality or safety.
Additionally, the FDA advised against purchasing and using counterfeit versions of the following medications:
- Paracetamol (Biogesic) 500 mg Tablet
- Phenylpropanolamine hydrochloride + Chlorphenamine Maleate + Paracetamol (Decolgen Forte) 25 mg/2 mg/500 mg Tablet
Consumers were reminded to purchase drug products only from FDA-licensed establishments.
The FDA has also warned all establishments and outlets against selling or dispensing these counterfeit products, emphasizing that such actions violate Republic Act No. 9711, the Food and Drug Administration Act of 2009, and Republic Act No. 8203, the Special Law on Counterfeit Drugs.
Penalties will be imposed on anyone found selling counterfeit drug products said the FDA.
In addition to unregistered drug products and counterfeits, the FDA also cautions the public against medical device products that lack proper notification, registration, or a corresponding Product Notification Certificate.
These include “Climax, Zero and Playboy” (unregistered medical device products in foreign characters); “IDEAL VISION CENTER AQUA UV COMFORT MULTI-PURPOSE SOLUTION” (an unregistered medical device product), “RX DR. CARE NASAL OXYGEN CANNULA” (an unregistered medical device), “MEDX SILICONE STOMACH TUBE 16 FR.” (an unregistered medical device), “SURRMED HOT & COLD PACK” (an unnotified medical device product), and “2 IN 1 ANTI SNORING AND AIR PURIFIER” (an unnotified medical device product).
The FDA has warned all concerned establishments not to distribute, advertise, or sell these “violative medical device products” until they obtain the required Product Notification Certificate.
Failure to comply may result in regulatory actions and sanctions, the FDA said. (Zekinah Elize Espina)