FDA Issues Warning About Unauthorized Covid-19 At-Home Tests

The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. This unauthorized test may be packaged in a white and magenta box.

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California Boutique Recalls Diet Supplements For Containing Banned Sibutramine

Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny High Intensity Pills and or 365 Skinny Emergency Boutique, 30 day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain Sibutramine which is a controlled substance by the DEA.

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Counterfeit HIV Drug Alert: Gilead Warns of Fake Versions of Biktarvy and Descovy Sold to U.S. Pharmacies

Gilead has alerted potentially impacted pharmacies to investigate the potential for counterfeit or tampered Gilead medication sold by distributors not authorized by Gilead that may be within their recent supply and to remain vigilant to the potential for this to occur in the future. The authenticity and safety of Gilead-branded medicines can only be secure when obtained directly through Gilead’s authorized distributors.

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ED-Marketed Dietary Supplement Recalled Due to Presence of Prescription Drugs

This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients in FDA approved products for the treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in Adam’s Secret Extra Strength products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

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FDA Puts All Mexico-Produced Hand Sanitizers on Import Alert

Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements. This marks the first time the FDA has issued a countrywide import alert for any category of drug product.

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Methanol-Contaminated Rubbing Alcohol Recalled by FDA

This is a reprint of an FDA Alert. Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company. Company Name: Essaar Inc.…

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