Granules Pharma Recalls Diabetes Drug Metformin HCI Extended-Release Tablets

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Granules Pharmaceuticals, Inc. recalled twelve (12) lots of type 2 diabetes medication Metformin hydrochloride Extended-Release, in the form of 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.

Chantilly, Virginia-based Granules Pharma, a R&D and manufacturing subsidiary of Hyderabad, India-based Granules India Ltd., recalled Metformin HCI ER tablets, USP 750mg within expiry, packaged in 100 and 500 count bottles.

However, Granules Pharma confirmed that its Metformin HCI ER tablets, USP 500mg and its Metformin Hydrochloride Immediate Release (IR) tablets, USP are not affected by the recall. FDA testing has not shown NDMA in IR Metformin products of any manufacturer.

Granules agreed to recall all 12 lots distributed in the U.S. market out of an abundance of caution after its test results showed that one lot of Metformin HCL it tested showed NDMA levels in excess of the ADI. These were distributed across the U.S. directly to distributors, and retailers.

The company is yet to receive any adverse reports after using the recalled product. It has urged anyone with an existing inventory of the product to quarantine the recalled lots immediately, while it is arranging for return of the entire recalled product.

This recall follows similar recalls issued by five others drug companies for the drug with the same issue over the past one month and more. The companies include Amneal Pharma, Marksans Pharma, Teva Pharma, Apotex and Lupin Pharma.

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.

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 glycemic control in adults and children with type 2 diabetes mellitus, particularly in over weight patients.

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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