FDA Urges Companies to Be ‘Recall Ready’ Following Baby Formula Recall Issued Months After Contamination Reported

FDA Recall Ready Notice Overview:

• Who: The U.S. Food and Drug Administration (FDA) has issued guidance to help companies prepare to quickly and effectively remove products from the market.
• Why: The FDA says it is making sure dangerous products get recalled in a timely manner.
• Where: The notice affects the United States.

The U.S. Food and Drug Administration (FDA) is urging companies to be prepared to recall their products quickly if need be so that dangerous products are not left on the market too long, endangering the public. 

The news comes after it was revealed that contaminated Abbott Nutrition baby formula remained on sale for months after the company knew the product may have been contaminated. The formula is now being investigated in relation to two infant deaths.

On Mar. 3, the FDA announced it had finalized new guidance to help companies prepare to quickly and effectively remove violative products from the market. 

The guidance describes steps companies should take before a recall is necessary to develop recall policies and procedures.

The procedures urge training, planning and record-keeping to reduce the time a recalled product is on the market and “limit the public’s exposure to risk.”

The FDA encourages companies to use electronic communications to quickly identify and provide certain product information when alerting people about a recall and also urges companies to act quickly to initiate a recall when public health is at risk.

The administration said a recall should be done prior to completing an investigation into the cause of the problem. 

Voluntary Recalls Fastest Way To Remove Potentially Harmful Products, FDA Says

Voluntary recalls are the fastest and most effective way for a company to remove potentially harmful products from the market to help keep consumers safe, FDA Associate Commissioner of Regulatory Affairs Judith McMeekin said. 

A recalling company may act on its own initiative, or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product, but a voluntary recall is typically faster. 

The FDA has the authority to force recalls of certain products in particular circumstances, such as controlled substances, biological products, human cells, tissues and cellular and tissue-based products, medical devices and foods. 

“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,” McMeekin said.

The news comes as United States senators are demanding Abbott Nutrition hand over documents related to recalls of its baby formula after it was revealed the company may have known about contamination since September last year.

On Feb. 25, Senators Patty Murray (D-Wash.) and Bob Casey (D-Pa.) sent a letter to Abbott CEO and chair Robert Ford demanding the company explain the delay in its recall.

On Feb. 28, a second infant death prompted an expansion of the Abbott baby formula product recall, initially announced Feb. 17. 

Do you think companies need to act faster to recall potentially harmful products? Let us know in the comments!

If your child became sick after consuming the recalled baby formula, you may be able to join a class action lawsuit investigation and obtain compensation (links to paid attorney content).

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