FDA strengthens Public Warning and Notification of Recalls

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

On January 18, 2018, the U.S. Food and Drug Administration, FDA, published a draft guidance for industry and FDA staff that better describes FDA’s policy on public warning and notification of recalls. The 12-page draft guidance covers FDA-regulated products including food, drugs, medical devices and cosmetics. Comments and suggestions regarding this draft document should be submitted within 60 days of publication.

According to the FDA the proposed document "gives industry clear direction on how to navigate and work with the FDA to make sure that recalls are communicated promptly. Ultimately, it will better empower consumers by providing more timely and more accurate information on recalled products". Additionally, the draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient.

The public’s primary source for recall information is FDA’s weekly, web-based Enforcement Report. Historically, only recalls that have already been classified into one of three categories based on the severity of the hazard have been listed in the report (Class I: high risk, Class II: intermediate risk, Class III: low risk). This enables consumers to better understand the severity of the problem posed by a recalled product so they can take appropriate action. FDA also provides guidance to companies on their recall strategies, taking into account the seriousness of the hazard presented by the recalled product.

The risk classification of the recall may sometimes take a long time when FDA needs to conduct a complex evaluation. Therefore, FDA has decided that the public would benefit by having recall information as soon as possible, even though further evaluation remains to be done. The recall classification according to the FDA is the following:

• Class I: Reasonable probability that use/exposure will cause serious adverse health consequences or death.
• Class II: Use/exposure may cause temporary or medically reversible adverse health consequences, remote probability of serious adverse health consequences.
• Class III: Use/exposure is not likely to cause adverse health consequences.

Recalls which present examples of serious hazards to health such that a public warning may be warranted include:

• Recalls of medical devices which may malfunction and lead to incorrect dosing of drugs or blood volumes.
• Recalls of sterile injectable drug products with particulate matter.
• Recalls of drug products associated with reports of death or other serious adverse events.

FDA will include “not-yet-classified” recalls in the weekly Enforcement Report, even while classification work is still ongoing. "Posting “not-yet-classified” recalls will not affect current FDA protocols for working with companies to ensure that they quickly alert entities in the supply chain as soon as they have identified a problem with their marketed product". In addition, "FDA will continue to monitor the recalling company’s actions to correct or remove products held by retailers, pharmacies, grocery stores, and hospitals". Whether firm-initiated or FDA-requested recalls, in every case FDA oversees a company’s recall strategy and assesses the adequacy of the recall. FDA may issue public warnings in a variety of forms, including, press releases, emails, and web and social media postings. FDA will generally provide a timeframe for when the company should issue a public warning based on the circumstances of the individual recall. While timeframes will vary depending on the recall, these firms should generally issue a public warning within 24 hours of FDA notifying the company it believes a public warning is appropriate.

FDA generally gives firms the first opportunity to prepare and issue public warnings during recalls. For instance, for company-initiated recalls, the recalling companies are expected to develop their own recall strategy. Recall strategy addresses, for example, whether a public warning is needed and how it will be issued. When FDA believes that a public warning is appropriate and the recalling company does not include one in its initial recall strategy, FDA will generally request one from the recalling company.

For more information please see FDA´s News & Events Press Announcements.