FDA Issues Final Guidance on Conducting Recalls

FDA issued a final guidance document on conducting recalls - Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff.  The document can be found here:  LINK

Your own recall procedures should reflect what is in the guidance.

A few key items to note:

• Firms should issue public warnings for urgent situations to alert the public that a product being recalled presents a serious hazard to health, and where other means for preventing the use of a recalled product appear inadequate. This is especially the case "when retail level consignees cannot identify persons" to whom the product was sold or  "when a recalled product has been widely distributed."  It may not be as important when recalled products have only been distributed to direct accounts and the recalling firm has records that show exactly where the products have gone.  In this case "a prompt and effective communication to such accounts informing them of the recall may be adequate to prevent the use of a recalled product, such as the case when a product is still in the warehouse."

• "The FDA generally gives firms the first opportunity to prepare and issue public warnings during recalls. For instance, for firm-initiated recalls, recalling firms are expected to develop their own recall strategy."  However, " In some situations, the FDA may prepare and issue public warnings on its own initiative and in accordance with 21 CFR § 7.42(b)(2). This may occur, for instance, when the public needs immediate warning concerning a product and the firm has not issued a public warning or a firm’s public warning is deficient."

• A public warning should include: 

1. "information to help identify the recalled product including images, numerical product information (e.g., lot number, expiration date, serial number, unique device identification (UDI) number), packaging information or brand names; 
2. the geographic areas and dates of distribution of the affected product; 
3. a thorough description of the product defect, health hazard involved, and reason(s) for recall (e.g., product testing, environmental sampling, etc.); 
4. the name and contact information for the recalling firm; 
5. instructions to consumers or users; f) the number and nature of any illnesses/injuries/complaints associated with the product, related to the product defect; and 
6. a description of common symptoms of any illness of concern. The headline of the public warning should include the brand name, type of product, and the hazard prompting the recall."
7. "In some cases, it may also be necessary to include the recalling firm’s supply-chain relationships in order to alert the public of the product being recalled. When possible, the FDA encourages firms to provide specifics about firms it sold product to in order to help people better identify and avoid recalled product."

• A public warning should not include information that detracts from the warning.  "Public warnings should not contain content that detracts from or defeats the purpose of the warning. Brief and succinct warnings are generally better at informing consumers of a product hazard and helping consumers understand the importance of avoiding the product. On the other hand, messages that cloud or lengthen a warning may distract a consumer and should be avoided. Generally, firms should not promote the qualities of the product being recalled, other products sold by the firm, or the firm in general, as part of a public warning. Phrases such as “an abundance of caution,” that can be seen as trying to minimize the hazard, should not be used, for example, when illnesses or injury have resulted, or when there are positive results for pathogens associated with the finished product or ingredients."

• "It is critical that public warnings are distributed in a way that ensures that the information conveyed in the warning actually reaches the public. To this end, the FDA is open to different vehicles of dissemination that best convey the information of the particular recall. "  The firm must take the distribution area into account to ensure that the warning covers the entire distribution area of the product.

• FDA may or may not post a recall on their Recall webpage, such as in the case where the recall has not been distributed to the public.  However, "The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, whether they were requested by FDA or firm-initiated, and the specific action taken by the recalling firm."  "Information on all recalls will be provided in the FDA Enforcement Report, regardless of the level of the hazard. "