Marksans Pharma expands recalls of metformin hydrochloride tablets
It is due to NDMA content in some lots that exceed the acceptable daily intake limit of 96ng/day
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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