If a company is not willing to remove from the market a medical device, drug, biological product, or package that poses a significant health hazard to consumers, the Food and Drug Administration will request a recall in writing. Once the request from the FDA is received, a recall must be initiated by the manufacturer, utilizing the internal approved strategies discussed in last month's column.
If the product has been distributed to consumers, drafting a press release should be the manufacturer's first step. The manufacturer needs to determine whether this communication should be local, regional, nationwide, or global. For the broadest coverage, sending the press release to a news service such as the Associated Press might be appropriate. To expedite the recall, the press release should contain at least the following information:
1) A complete product description including any identifying product, lot, or UPC codes or numbers
2) Description of the reason for the recall
3) Method of distribution of the product
4) Instructions for the return of the recalled product or package
In addition to a press release, a manufacturer should also send recall notification letters to customers containing the same information as the press release. The inclusion of a picture of the product would also be helpful.
The local FDA district recall coordinator should be kept informed throughout the manufacturer's recall procedures, including review of the draft press release.
More detailed information on the regulations, guidance, sample press releases, and enforcement reports are located on the FDA's recall Web page.
--By Linda McBride, registered pharmacist
Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineers and the Regulatory Affairs Professionals Society.
