In a fourth recall for the diabetes drug Metformin in about a week because of a cancer-causing ingredient that may be present in higher than acceptable levels, Marksans Pharma Limited (MARKSANS.NS) has recalled Metformin Hydrochloride Extended-Release Tablets because they may also contain N-Nitrosodimethylamine (NDMA) in levels that are above the acceptable daily limit set by the U.S. Food and Drug Administration.

NDMA is classified as a probable human carcinogen that could cause cancer. The FDA has set the daily acceptable intake limit of NDMA as 96 ng/day. Metformin is used to improve blood glucose control in adults with Type 2 diabetes mellitus.

The recalled Metformin was sold in 500 mg dosages with a lot number of XP9004. It was packaged in 100-count bottles and has an NDC code of 49483-623-01. The affected medication is white to off white, capsule-shaped biconvex tablets that are debossed with “101” on one side and plain on the other side. It has an expiration date of 12/2020.

The affected Metformin medication was distributed by Time-Cap Labs nationwide to wholesalers that further distributed the drug to pharmacies. Labels of the recalled diabetes drug can be viewed here.

Questions about the Metformin recall can be directed to Irene McGregor, vice president of Regulatory Affairs at Time-Caps Labs at 631-753-9090, Ext 160, Monday through Friday from 8 a.m. to 5 p.m. EST or by email at imcgregor@timecaplabs.com.

Marksans Pharma Limited has not received any reports of adverse reactions due to the recalled Metformin medication. Consumers that have been prescribed the recalled Metformin should contact their healthcare provider if they experience any problems with taking the medication.

Shares of Marksans Pharma Limited stock were up 1.26% as of market close on Monday.

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