FDA Releases Draft Industry Guidance for Voluntary Recalls

FDA issued a draft guidance on how to issue a voluntary recall.  (This draft guidance is listed FDA's webpage Industry Guidance for Recalls which has a number of valuable links including Model Press Releases. - https://www.fda.gov/safety/recalls/industryguidance/default.htm)

"The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead  to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation" of federal regulations.

Firms should be recall ready.
1. General Preparations

• Identify appropriate personnel.
• Train personnel on their responsibilities.
• Establish a recall communications plan.
• Identify any reporting requirements associated with your products.
• Use adequate product coding.
• Maintain distribution records.

2. Specific Recall Initiation Procedures - A firm’s written recall initiation procedures should assign responsibility and describe the steps to 152 perform all actions related to initiating a recall, including the following:

• Ceasing distribution, shipment, and/or sales of affected product(s).
• Developing a recall strategy
• Notifying direct accounts about the product being recalled, including what should be done with respect to the recalled product

What should a firm do if there is an indication of a problem with a distributed  product?

• Identify the problem
• Investigate the problem.
• Make decisions and take action.
• Consult with FDA about the problem.

How should a firm initiate a voluntary recall?

• Promptly send recall communications to each affected direct account, and by issuing a press release or other public notice
• Follow the initiation procedures in its recall plan to implement the recall in accordance with 21 CFR 7.46

How does FDA work with a recalling firm to initiate a voluntary recall in a timely manner?

• Recall coordinators provide a recalling firm with information about the recall process and are available to work closely with 267 the firm throughout the course of the recall.
• A recalling firm located in the United States should contact a Division Recall Coordinator within the FDA Office of Regulatory Affairs (ORA).