Nearly 50,000 Claire's Packages Recalled; More ED Drugs In Supplements
Three makeup products tainted with asbestos Claire Stores recalled after initially refusing FDA's request, and second and third recalls of tattoo ink in 2019 are among health, beauty and wellness product recalls listed in agency's latest updates. FDA also ED drug sildenafil in another product marketed as a dietary supplement.
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FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms. Instead, on top of November guidance on mandatory recall authority and February guidance on recall public notifications, FDA is making clear its expectations for firms' preparedness for recalls and their responses when faced with removing products from store shelves.
The jewelry and cosmetics retailer announced March 11 that it is voluntarily recalling selected lots of three makeup products due to the “possible presence of asbestos fibers.” FDA issued a safety alert the previous week that has made Claire’s the latest poster child for cosmetics regulatory reform.
Between start of federal government partial shutdown on Dec. 22 and federal agencies' re-opening on Jan. 28, FDA Customs and Border Protection officials examining international mail shipments found ED drugs in six products and two weight loss ingredients approved in the US in four.