Contact: Diabetes drug Metformin recalled due to high levels of cancer-causing agent.
Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
Summary
Company Announcement Date:
October 02, 2020
FDA Publish Date:
October 05, 2020
Product Type:
Drugs
Reason for Announcement:
Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Company Name:
Marksans Pharma Limited
Brand Name:
Time-Cap Labs Inc.
Product Description:
Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 700 mg
Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall.
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