Marksans Pharma expands recalls of metformin hydrochloride tablets

05 Oct 2020 Evaluate

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 due to NDMA content in some lots is observed exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on result from 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.

Marksans Pharma together with its subsidiaries operates as an integrated international pharmaceutical company. The company’s business is distribution of pharmaceutical products.

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