Marksans Pharma freezes at upper circuit on voluntary expanding Metformin Hydrochloride tablets recall

The tablets are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

Oct 05, 2020 03:10 IST India Infoline News Service

Marksans Pharma
Marksans Pharma has intimated exchanges that the company is voluntarily expanding its earlier initiated recall on June 05, 2020, to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release tablets in the strength of USP 500 mg & 750 mg.

The recalls are being done due to NDMA content in some lots was 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.

Marksans explains in a regulatory filing that, NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the result from the laboratory test. NDMA is a known environment contaminant found in water and foods including meats, dairy products and vegetables.

Meanwhile, the tablets are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

Further, the company said they are continuing the manufacturing and distribution of this product on an ongoing basis by placing the appropriate corrective actions proactively.

As of March 2020, Marksans' exports to the USA for the Metformin extended-release tablets were of $1.43M only which constitutes less than 1% of the company's consolidated revenue.

On Sensex, during Monday's trading session, Marksans stock settled at the upper circuit limit of Rs54.20 per piece up 4.94%. 

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