NEW DELHI (dpa-AFX) - India-based Lupin Pharmaceuticals Inc. announced a recall of all batches of type 2 diabetes medication Metformin Hydrochloride Extended-Release Tablets, citing detection of N-Nitrosodimethylamine or NDMA, a probable human carcinogen.
The move comes after many other drug companies called back Metformin tablets after the U.S. Food and Drug Administration or FDA recommended over NDMA concerns.
Metformin Hydrochloride Extended-Release Tablets is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The drug is packaged in 60, 90 and 100 count bottles and was distributed across the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets.
In its statement, Lupin noted that additional analysis, as part of the ongoing assessment with the FDA, revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity NDMA.
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.
However, Lupin Pharma has not received any reports of adverse events related to the recalled drug to date.
The company asked patients to continue taking Metformin as stopping the drug could be dangerous. They can contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
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 FDA announced that it contacted five drug companies that manufacture Metformin to implement the drug's recall due to NDMA impurity. Apart from Lupin Pharma, the others in the list included Apotex, Amneal Pharmaceuticals, LLC, Actavis Pharma Inc., and Marksans Pharma Ltd.
In early June, FDA recommended that more pharmaceutical companies, who are manufacturers of the drug formulation, recall their products.
Apotex, Amneal, and Granules Pharmaceuticals, Inc., among others, have already called back their Metformin medication following FDA's warning.
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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