FDA warns public not to buy, use unregistered first-aid bandage

Published June 17, 2018, 4:42 PM

by Francine Ciasico

By Analou De Vera

Health authorities warned the public against the purchase and use of an unregistered first-aid bandage that is being sold in the market.

(MANILA BULLETIN)
(MANILA BULLETIN)

The Food and Drug Administration (FDA) identified the said medical device as ‘Medicare Antiseptic Plastic Strips with Acrinol.’

In its advisory 2018-187, the agency stated that its post marketing surveillance verified that the said product did not go through the registration process.

The FDA is encouraging the public not to purchase the said product and to remain vigilant against other medical devices that might not be duly registered with the agency.

“Since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public,” the FDA stated.

The agency advised establishments not to distribute the product until it has been covered by the appropriate authorization “otherwise, regulatory actions and sanctions shall be strictly pursued.”

The public is being encouraged to report if the said product is being distributed by utilizing the agency’s online reporting facility http://www.fda.gov.ph/ereport; or through e-mail [email protected]

 
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