Two metformin products recalled, more on the way

June 2, 2020

Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.

Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.

Both Apotex Corp and Amneal Pharmaceuticals have issued a voluntary recall of metformin hydrochloride extended-release tablets, and FDA said three additional companies will recall their ER metformin.

Apotex Corp is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level. However, Apotex stopped selling this product in the U.S. in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of that product, it said.

Amneal is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the US directly to wholesalers, distributors, retailers, and repackagers.

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The agency’s testing found that “certain extended release metformin products contain NDMA above the acceptable level,” FDA said.

“FDA is contacting companies with ER metformin above the acceptable level and will continue to take quick and appropriate action when needed to protect American consumers. We are committed to providing timely updates on our investigations and any recalls,” FDA said.

The FDA said that patients should not stop taking their prescription medications without first talking to their healthcare providers.

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In early February, the agency posted the results of its laboratory analysis showing NDMA levels in some samples of the metformin products it tested. Overall, the levels of NDMA found in metformin ranged from “not detectable to low levels” at the time.

According to the agency, no sample of metformin that was tested by the FDA exceeded the acceptable daily intake of NDMA.

In December, regulatory agencies outside of the United States recalled some metformin drugs due to low levels of the impurity, prompting FDA officials to test samples of metformin sold in the US.

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