'Mock' Recalls Suggested, But US FDA Isn't Joking About Recalling Products
FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms.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.
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Support To Grant US FDA Authority To Order Recalls Of All Drugs Grows With Bill Introduced In Senate
Sen. Gary Peters says FDA should have the authority because relying on drug marketers to voluntarily recall products the agency has deemed unsafe isn’t sufficient to protect public health. He notes that manufacturers of OTC hand sanitizers imported from Mexico and found to contain methanol haven’t cooperated with the FDA on recalling the products.
Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.
FDA warns Wave Miami that its Lipro Dietary Capsule weight loss product contains tadalafil and the firm has not recalled it despite requests from the agency. FDA says the firm makes claims including helping users lose 30 pounds in 30 days.