FDA Final Guidance – Warning of Recalls

The U.S. Food and Drug Administration (FDA) recently released the final guidance entitled “Public Warning and Notification of Recalls.” The announcement of the guidance has been published in the Federal Register on February 8, 2019.

For the fiscal year 2018, FDA reports a total of 7,420 recalls with 831 that were classified as the highest risk. Acording to the agency, FDA will routinely provide more information on recalls and other safety issues that have happened and also communicate more frequently and, in many cases, directly to consumers through the agency’s social media. Therefore, the final guidance for industry and FDA staff

• outlines circumstances when a company should issue a public warning about a voluntary recall,
• describes the general timeframe for companies to issue such a warning,
• discusses what information should be included in a public warning,
• describes situations where the agency may take action to issue its own public warning,
• describes the agency´s policy for moving forward with posting recalls to the FDA’s Enforcement Report (a web listing of all recalls monitored by the FDA).

FDA states that in accordance with the draft version of this guidance, the agency already issued alerts or consumer warnings related to many products (including valsartan, losartan and irbesartan).

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