Nostrum Laboratories, Inc. has extended its recall for type 2 diabetes medication Metformin Hydrochloride Extended-Release (ER), in the form of 750 mg oral film-coated tablets, for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.
In early November, Nostrum Labs had recalled 2 lots each of Metformin HCl ER 750 mg tablets and 500 mg tablets. The NDMA levels in these tablets were found to be above the FDA’s permissible ADI limit of 96 ng/day.
Nostrum Labs has now added one more lot of Metformin HCl ER, USP 750 mg tablets (generic equivalent to Glucophage Tablets) in the latest recall for similar NDMA level issue. The lot number is MET200501 with expiry date of July 2022.
The Kansas City, Missouri-based company is yet to receive any reports of adverse events related to this recall.
The product is an oral antihyperglycemic drug used in the management of type 2 diabetes. It is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.
The affected product is packaged in HDPE bottles of 100 tablets and was distributed across the U.S. to wholesalers. It can be identified as an off-white oblong tablet debossed with “NM7”.
The company has urged pharmacies that have the recalled product to return it to the place of purchase. It also warned consumers to consult a healthcare professional to obtain a replacement or a different treatment option as it could be dangerous for patients with type 2 diabetes to stop taking their Metformin.
The FDA began testing Metformin in the U.S. supply after it become aware of NDMA in some Metformin products in other countries in late 2019. In May, the agency recommended pharmaceutical companies who are manufacturers of the drug formulation to recall their products.
Since then, there have been a slew of pharma companies, including Apotex, Amneal, Actavis, Lupin, Nostrum, Granules, Teva, Sun, Bayshore and Marksans, who have announced recall of the product.
NDMA, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including meats, dairy products, and vegetables.
The elevated NDMA contamination levels also caused several recalls in the U.S. for heartburn medication Ranitidine, sold under the trade name Zantac among others, since September 2019 after the FDA issued an alert.
The FDA has also been investigating NDMA and other Nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers or ARBs since last year.
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