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.
