Thursday, March 3, 2022

FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

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US Food and Drug Administration

FDA Urges Companies to be 'Recall Ready' to Protect Public Health as Part of Final Guidance for Voluntary Recalls

Today, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public's exposure to risk.

"Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe," said Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. "It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans' exposure to potentially harmful products."

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