When a medical device, drug, or biological product or package poses a public health risk, either to humans or animals, a recall must occur. The determination of the risk and the initiation of a recall can be by a manufacturer, at the request of the Food and Drug Administration (FDA), or by the FDA order under statutory authority.
In order to be prepared in the event of a recall, here are three steps recommended by the FDA:
1) A strategy should be in place to define the initiation and execution of a recall. A few items that ought to be included in the strategy are details on the notification of the FDA District Recall Coordinator, the depth of recall, and if public warnings are necessary.
2) The identification of the medical product(s) by lot number. While carrying out a recall, the ease of product identification can make an effective recall possible.
3) The initiation and maintenance of records for determining the location of distributed product to be recalled.
For more information on preparing for a recall, please see the Guidance for Industry entitled Product Recalls, Including Removals and Corrections, located on the Web site of FDA and 21 CFR § 7.
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.
