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Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets because their levels of NDMA, a “possible human carcinogen,” have been shown to exceed the daily limit of 96 nanograms.
Metformin tablets are used to treat type 2 diabetes and are designed to lower glucose levels. The withdrawal 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. Another 7 drug companies have recalled metformin hydrochloride extended-release tablets due to their carcinogenic potential, according to Mediafax.
Product codes
The FDA (US Drug Regulatory Authority) 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.
The measure applies to the following products (which can be identified by codes):
Metformin Hydrochloride Extended Release Tablets, USP 500mg:
49483-623-09
49483-623-01
49483-623-50
49483-623-10
Metformin Hydrochloride Extended Release Tablets, USP 750mg:
49483-624-01
At the beginning of the year, the European Union made a similar decision and blocked the sale of all drugs containing ranitidine, widely used by Romanians in digestive disorders.
In December 2019, several batches of the drug Debridat, also used for children and babies, were recalled in Romania, as the container could have contained a foreign metal body as a result of an incident that occurred on the filling line. , at the place of manufacture in France. The announcement was made by the Romanian National Agency for Medicines and Health Products:
