FDA Increases Efforts to Flag Public Warnings, Recalls

FDA Commissioner Scott Gottlieb announced that the agency is ramping up its efforts to improve public warnings and recall notifications.

The FDA has finalized guidance on when companies should issue public warnings about recalls, including a timeframe for issuing them. It also describes information that should be included in the warnings and circumstances when the agency can issue its own warning if the company’s is inadequate.

For example, the guidance urges companies to include information in their warnings that helps consumers identify the recalled product. This can be done with numerical product information (such as lot number, expiration date, serial number); images; packaging information or brand names; the geographic areas and dates of distribution of the product; and a detailed description of the product’s defect and resulting health hazard.