July 12, 2024

FDA Urges Companies to Be Recall Ready to Protect Consumers

The FDA is urging companies to be “recall ready” to protect consumers. This guidance is part of finalized guidance for voluntary recalls. Companies should prepare to be able to quickly and effectively remove products from the marketplace. The guidance describes steps that the companies should take before a recall is deemed necessary.

FDA Urges Companies to Be Recall Ready to Protect Consumers

These steps include training, planning, and record-keeping to reduce the time that a recalled product is on store shelves. Those actions limit the public’s exposure to potential risk such as undeclared allergens or pathogens.

Judith McMeekin, Pharm. D., Associate Commissioner of Regulatory Affairs for the FDA said in a statement, “Voluntary 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. It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”

When a problem is identified, either through consumer complaints, FDA actions, or from the company itself, the company can voluntarily recall the item, or, less commonly, the FDA has the authority to require recalls under special circumstances, which usually include pathogens or other issues that are dangerous to human health.

The final guidance describes how companies should have adequate product coding and up-t0-date distribution records to facilitate faster and more accurate recalls. Electronic communications are encouraged to quickly identify and provide product information when alerting the public.

The guidance urges companies to act quickly and start a recall when public health is at risk. The recall should begin before an investigation into the case of the problem has been completed. Recall procedures to quickly inform the entire distribution chain should also be implemented.


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