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FDA issues warning against buying, using 5 unregistered drug products

Published Oct 9, 2024 09:01 am

The Food and Drug Administration (FDA) has issued a public health warning against the purchase and use of five unregistered drug products.

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(FDA Philippines)

In an advisory posted on its website on Wednesday, Oct. 9, the FDA advised the public against the purchase and use of the following products: OTC Metronidazole Vaginal Effervescent Tablets – Jiaxiaozou Yindao Paotengpian, Zhitong Huazheng Jiaonang, Tinidazole Tablets 0.5 g, Yatai® Clindamycin Hydrochloride Capsules 0.15 g, and Sodium Bicarbonate Injection 10 ml.

The FDA said its Post-Marketing Surveillance (PMS) activities have verified that these drug products "have not gone through" its registration process.

Since these products "have not been issued proper authorization" in the form of a Certificate of Product Registration, the FDA said it "cannot guarantee their quality, safety, and efficacy."

"Consumption of such violative products may pose potential danger or injury to health," the FDA added.

Under Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009,” the agency reiterated that the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from the FDA is “prohibited.”

“All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have obtained the appropriate authorization; otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA said.

Moreover, the FDA urged the public to "always check if the products are registered" with the agency by using the FDA Verification Portal feature accessible at https://verification.fda.gov.ph.

Meanwhile, the FDA requested all Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) to “ensure that these products are not sold or made available in their localities or areas of jurisdiction.”

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