Marksans Pharma expands recalls of metformin HCL tablets

Marksans Pharma expands recalls of metformin HCL tablets

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Drug Recall FDA
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Last Updated on October 4, 2020 by The Health Master

Marksans Pharma is voluntarily expanding its earlier initiated recall on June 05, 2020, to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg & 750 mg. It is due to NDMA content in some lots that exceed the acceptable Daily Intake Limit (ADI) of 96ng/day.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the result from a laboratory test. NDMA is a known environment contaminant found in water and foods including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg & 750 mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.


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