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US FDA's Expectations And Firms’ Responsibilities Clarified In Voluntary Recalls Final Guidance

Executive Summary

Final guidance describes in greater detail than draft published in 2019 the agency’s expectations for marketers and other businesses’ responses when they need to recall FDA-regulated products.

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'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FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms.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.

Recalls With Potential For Serious Health Risks Will Identify Points Of Sale

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