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  1. CDER Small Business & Industry Assistance (SBIA)

The Key Elements of Being “Recall-Ready”

CDER Small Business and Industry Assistance Chronicles

Podcast and newsletter

  Podcast Transcript

Preparation is key when managing drug product recalls. It is critical for firms to be “recall ready” so that they can act quickly and effectively to protect the public from violative products on the market.  A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling firm may act on its own initiative, or FDA may inform the firm that a distributed product violates the law and recommend that the company recall the product. 

FDA has released a final guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, which outlines preparations that firms should consider making to establish recall initiation procedures to ensure faster and more accurate recall actions. FDA encourages companies to communicate quickly with supply chain consignees, such as distributors and the public about a voluntary recall.

Facilitating timely initiation of a voluntary recall: There are many steps that a firm in a product distribution chain can take to prepare in advance of a recall. Specific personnel, and sometimes a “recall team,” should be assigned recall-related responsibilities and possess the authority to take the steps needed to implement a product recall when necessary. They should be trained regularly so they have a thorough understanding of the recall procedures. If complex recalls are anticipated, the firm may want to consider additional preparatory steps, such as mock recalls, to verify the firm’s recall readiness.  The firm should also consider establishing metrics and taking actions to improve its recall plan.

A recall communication plan should address internal communications, communications with FDA, and communications to direct accounts or the public if a recall is deemed necessary. A direct account is the first consignee in a firm’s distribution chain, and a consignee is anyone who received, purchased, or used the product being recalled. FDA recommends that firms maintain draft templates for issuing recall communications. FDA also encourages firms to use electronic methods for conveying voluntary recall communications. Model recall communications are available on FDA’s webpage.

A firm should know whether its product is associated with any legal or regulatory requirements to report a problem to FDA. Firms should also use sufficient coding (required or not) of regulated products to enable positive lot identification and to facilitate the recall of all violative lots. Product coding may help a recalling firm accurately define and limit the scope of the recall and allow consignees to separate violative product lots from unaffected lots and may help consumers recognize an affected product. In addition, the firm should maintain distribution records to facilitate the location of products being recalled. These records should be retained for a period that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable records retention regulations.  

Initiating a recall: FDA recommends that firms consider preparing, maintaining, and documenting written procedures for initiating a voluntary recall and performing actions related to initiating a voluntary recall. These written procedures should assign responsibility and describe the steps to perform actions; develop a recall strategy; notify direct accounts about the product being recalled, including what should be done with respect to the recalled product; and when appropriate, notify the public about a product that presents a health hazard. The recall communication should include instructions for the method that the direct account can use to respond to the notification, e.g., written, telephone, or electronic communication, and should include the recalling firm’s points of contact for follow-up communications.

A firm should initiate a voluntary recall by notifying each of its affected direct accounts about the recall and issuing a press release or other public notice as appropriate.  FDA recommends that the firm follow the initiation procedures in its recall plan. FDA will generally request copies of the firm’s issued or proposed recall communications and will recommend changes as appropriate, but the firm does not need to wait for FDA’s review prior to initiating the recall. 

Direct accounts should be given clear instructions regarding appropriate disposition of recalled product, which may be subject to federal, state, and local requirements. The firm should also clearly identify the level in the distribution chain to which the recall is to extend and provide instructions to direct accounts to extend the recall to their own direct accounts if the product could have been further distributed. Follow-up communication may be needed for any direct account that fails to respond to a recall communication. 

In addition to any product-specific regulatory requirements related to identifying, investigating, and reporting product problems, FDA recommends that all firms:

  • Identify the problem: Implement procedures to identify indicators that there may be a problem with a distributed product that suggests it may be in violation of applicable laws.
  • Investigate the problem: Assign responsibility and describe steps to investigate a problem with a distributed product. The recalling firm need not delay initiation of a voluntary recall pending completion of the investigation.
  • Make decisions and take action: Assign responsibility and describe steps to ensure that decisions are made to control defective and potentially harmful products in a timely manner, including addressing whether to initiative a voluntary recall, the appropriate scope and depth of the recall, and the need to discontinue production and distribution of the affected product.
  • Consult with FDA about the problem: FDA Recall coordinators may assist with developing an appropriate recall strategy, reviewing the firm’s communications, and monitoring the destruction, reconditioning, or disposition of the recalled product. A recalling firm located in the U.S. should contact a Division Recall Coordinator within the FDA Office of Regulatory Affairs (ORA). If the firm is located outside of the U.S. and is recalling a product exported to the U.S., the recalling firm should contact ORA Headquarters.

FDA officials may initiate discussions with a firm about a product problem, at times recommending that the firm cease distribution and recall the product if the Agency determines that the product violates the law.

Under certain circumstances, FDA may also request that a firm initiate a recall. FDA must make all of the following determinations before making such a request:

  1. That a product that has been distributed presents a risk of illness or injury or gross consumer deception;
  2. That the firm has not initiated a recall of the product; and
  3. That an Agency action is necessary to protect the public health and welfare.

If a firm agrees to recall a product based on an FDA recommendation or request, then the action is still considered a voluntary recall.  If a firm’s actions do not adequately protect the public from a violative product, FDA may consider taking other appropriate actions.

FDA is committed to working cooperatively with a recalling firm whenever possible to facilitate the orderly and prompt removal of, or correction to, a violative product in the marketplace.

For additional information on recalls, visit Recalls, Market Withdrawals & Safety Alerts and Industry Guidance for Recalls.

Renu Lal, Pharm.D.CDER Small Business and Industry Assistance

Issues of this newsletter are archived at www.fda.gov/cdersbiachronicles

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.


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