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FDA warns vs purchase, use of unregistered, counterfeit products

Published Nov 13, 2023 06:09 am

The Food and Drug Administration (FDA) warned the public on Monday, Nov. 13 against the purchase and use of six unregistered products that have not undergone its evaluation process.

FDA-Advisory-No.2023-2317 (1).png
Photo from FDA website

The unregistered drug products are “Benzalkonium Chloride (Benzellin) 0.13% Tincture 7.5mL,” “Angel’s Flo Isopropyl Alcohol 70% Solution 100 mL,” “Avant Guard Ethyl Alcohol 70% Solution with Moisturizer 150 mL,” “Spring Clean Isopropyl Alcohol 70% Solution Moisturizer 250 mL,” and “Ultra Sulit Isopropyl Alcohol with Moisturizer 70% Solution 500 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 advises against purchasing and using counterfeit versions of Phenylephrine HCl + Chlorphenamine Maleate + Paracetamol (Neozep®Forte) 10mg/2mg/500mg 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.

It also alerted healthcare professionals and the general public not to buy or consume these unregistered products for their safety.

Penalties will be imposed on anyone found selling counterfeit drug products, said the FDA.

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