FDA Issues Guidance on Voluntary Recalls

On Thursday, the U.S. Food and Drug Administration (FDA) finalized guidance to help companies prepare to remove violative products quickly and effectively from the market. The guidance describes steps companies should take before a recall is necessary to develop recall policies and procedures that include training, planning, and record-keeping to reduce the time a recalled product is on the market, thus limiting the public’s exposure to risk.

A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative, or the FDA may informed the company that a distributed product violates the law and recommend the company recall the product. The FDA retains its authority to require recalls of certain products in particular circumstances, including controlled substances, medical devices, and food.

Under the final guidance, the FDA explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions. It encourages recalling companies to use electronic communications to quickly identify and provide certain product information when alerting the public about a voluntary recall.

The guidance additionally urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of a problem. The FDA recommends companies develop recall procedures to quickly inform their entire distribution chain, allowing individuals to rapidly identify affected products and recall downstream products when necessary.

Additional information is available here.