'Recall ready': FDA urges companies to comply with drug recall guidance
The FDA has finalized guidance to help companies quickly recall products and take the necessary steps before a product reaches the recall stage, as part of work pull violative products and keep them out of the hands of consumers.
Initiation of Voluntary Recalls offers guidance for companies to develop procedures including training, planning and record-keeping to reduce the time a dangerous product is on the market and limit the risk of exposure. The FDA can recall controlled substances, biological products, human cells, tissues and cellular and tissue-based products, as well as medical devices and food.
The report also explains how to keep records and product coding. Since recalls affect the entire supply chain, the FDA says that a procedure should be in place to quickly inform everyone in line, from downstream suppliers to wholesalers and vendors. The final guidance builds off of a draft from April 2019.
“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,” said Judith McMeekin, the FDA’s associate commissioner of regulatory affairs. “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.”
There have been 14 drugs recalled since the start of 2022 alone, according to the FDA’s website. Most recently, Braun Medical was forced to voluntarily recall five lots of its 0.9% Sodium Chloride for Injection USP 250ML due to fluid leakage or low fill volume. That recall was announced Thursday.
In 2021, there were 77 drugs recalled. Most notably was the industry’s issues with NDMA contamination, a known probable human carcinogen with cancer-causing potential.
In January, Viona Pharmaceuticals recalled 33 lots of metformin hydrochloride after finding traces of NDMA. But Pfizer battled issues with the contamination of its anti-smoking drug Chantix in June, July, August and September for NDMA. Lots were distributed in the US, US Virgin Islands and Puerto Rico from May 2019 to September 2021. In 2018, blood pressure drug valsartan was pulled for the same reason. Last January, Nostrum Laboratories twice voluntarily recalled its generic metformin. In November 2020, a batch of 500 mg tablets was recalled for the same reason.