March 11, 2022

FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be 'Recall Ready'

The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the market.” In a news release describing the final guidance, FDA’s Associate Commissioner of Regulatory Affairs Judith McKeen explained: “[v]oluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe.”

The guidance covers voluntary recalls of food, drugs, devices, biological products, cosmetics and tobacco. It stresses the importance of being “recall ready” at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for potential recalls and implement recalls. It also offers recommendations on four specific questions, which are addressed briefly below.

How Should a Firm in a Product Distribution Chain Prepare to Facilitate Timely Initiation of a Voluntary Recall?

  1. Assign appropriate personnel recall responsibilities. If the recall chain would be complex, consider establishing a “recall team.”
  2. Train personnel. Also consider conducting mock recalls to verify the firm’s recall readiness.
  3. Establish a recall communication plan. The plan should address communications internally, with FDA, with distributors and with the public. FDA encourages the use of electronic communications.
  4. Identify any relevant reporting requirements. For example, the firm should understand when and what type of information it needs to report to FDA.
  5. Use adequate product coding. This enables a firm to identify and to recall violative lots. Adequate coding can help a recalling firm define and limit the scope of a recall.
  6. Maintain distribution records. These records should be maintained to facilitate quick location of recalled products and should be retained for a period longer than the shelf life and expected use of the product. Further, any entity that receives the product and further distributes it should maintain distribution records.

FDA recommends documenting all procedures for initiating a recall and performing actions related to initiating a recall to minimize delays created by uncertainty. The written procedures should assign responsibility and describe the steps to perform actions such as:

  1. Cease distribution, shipment, and/or sales of affected product(s);
  2. Develop a recall strategy as set forth in 21 CFR 7.42;
  3. Notify direct accounts about the product being recalled, providing response instructions to notified direct accounts, and providing instructions for appropriate disposition of a recalled product; and
  4. Notify the public.

What Should a Firm Do if There Is an Indication of a Problem With a Distributed Product?

FDA recommends that firms implement procedures to identify indicators of any issues warranting a recall. Such indicators may include adverse event reports, consumer complaints or internal reports of a product specification deviation.

A firm’s procedures should indicate who is responsible for investigating any potential issues and any steps involved in the investigation. Importantly, a recalling firm need not delay the initiation of a voluntary recall pending the completion of an investigation.

The procedures should also assign decision-making responsibility by identifying who determines whether to initiate a recall, the appropriate scope of the recall, the depth of the recall and whether there is a need to discontinue production of the product. FDA encourages firms to reach out to the appropriate FDA recall coordinator with any questions.

How Should a Firm Initiate a Voluntary Recall?

Voluntary recalls should be initiated by notifying the affected direct accounts and issuing a press release or other public notice if necessary. The date of the firm’s first communication about a recall is the date FDA considers the date of initiation. FDA notes that it generally requests copies of the firm’s issued or proposed communications and will review and recommend changes as appropriate. Importantly, a voluntary recall need not be delayed pending FDA’s review of the recall strategy or communications.

A recalling firm should clearly identify the level in the distribution chain to which the recall should extend. The recall firm should also, if necessary, provide instructions to direct accounts to extend the recall to their own direct accounts. Further, a firm that initiates a recall because it believes a product is violative should notify FDA immediately.

How Does FDA Work With a Recalling Firm to Initiate a Voluntary Recall in a Timely Manner?

FDA provides recall coordinators who act as the agency’s points-of-contact. The guidance emphasizes that these coordinators are available to work closely with a recalling firm throughout the recall process.

FDA may initiate discussions with a firm about a product issue and recommend the product be recalled. Under certain circumstances, FDA may also request that a recall be initiated.

FDA further notes that if a firm fails to initiate a recall effectively, “FDA may consider taking other appropriate actions.”

Conclusion

While this guidance is nonbinding, manufacturers and companies within a product’s distribution chain should keep FDA’s recommendations (and applicable recall-related regulations) in mind when planning for or initiating a voluntary product recall.

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