Metformin recalls continue


Recalls of metformin products due to higher levels of the probable carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than allowed continue.

Several months after the first metformin recall, Nostrum Laboratories this week said it is voluntarily recalling two lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level.

Related: Major metformin recalls underway

"The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day,” the company said in a press release.

The metformin — indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus — is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.

The recalls began this summer, when FDA found elevated NDMA levels in products from five different manufacturers.

At the time, Apotex Corp recalled all lots of its metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to the retail level.

Similarly, Amneal recalled 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.

Related: Sun Pharma recalls 1 lot of metformin due to NDMA levels

In September, Sun Pharmaceuticals also recalled one lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level due to a higher than allowed level of NDMA.

NDMA is a probable human carcinogen and a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables, Nostrum said.

However, Nostrum has not received reports of adverse events related to the recall.

FDA published a recalled metformin list, including details about metformin products that have been recalled.

Read more: Two metformin products recalled, more on the way

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