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Indian pharmaceutical company Marksans Pharma Limited is recalling extended-release metformin hydrochloride tablets because their levels of NDMA, a “possible human carcinogen,” have been shown to exceed the daily limit of 96 nanograms, according to CNN.
The announcement was made this week by the FDA, the US National Food and Drug Administration.
Metformin tablets are used to treat type 2 diabetes and are designed to lower glucose levels. The measure applies to metformin tablets between 500 mg and 750 mg, which are sold under the brand name Time-Cap Labs, Inc. However, this is not the only product considered by the US authorities.
In the last year, several metformin-based medications were found to contain too much NDMA. Seven other drug companies have recalled metformin hydrochloride tablets due to their carcinogenic potential.
The FDA is still investigating the origin of the ingredient NDMA and how it gets into products used to treat diabetics. Indian company Marksans Pharma Limited did not disclose the dosage of NDMA in the recalled products, according to Mediafax.
