Indian pharmaceutical company Marksons Pharma Ltd is recalling metformin hydrochloride extended-release tablets because NDMA, the level of “potential human carcinogens”, exceeded the acceptable daily intake limit of n 96 nanograms per day this week. Food and Drug Administration (FDA).
Metformin tablets are used to treat type 2 diabetes and are designed to lower glucose levels.
The recall applies to metformin tablets between 500 mg and 750 mg, according to Time-Cap Labs, Inc. Sold under brand name.
The recall extends the previous recall of the same product from this summer. But it is just one of many metformin products that have been found to contain NDMA in the last few years. Seven other pharmaceutical companies have issued recalls of metformin hydrochloride extended-release tablets due to their carcinogenic contents.
The FDA is still investigating where NDMA comes from and how it ends up in metformin products. Most of the levels found in herbs are generally low and come in FDA-approved daily intakes, but the drugs recently recalled are higher than that. However, Marksons Pharma Limited, India, has not disclosed how much NDMA is included in its previous products.
This recall applies to the following products, which can be identified by their national drug code numbers listed below (national drug codes may be used by the FDA to search and identify search online products). The tablets are filled with either 101 or 102 on one side and plain on the other.
Metformin hydrochloride extended-release tablets, USP 500 mg:
90 calculations: 49483-623-09
100 calculations: 49483-623-01
500 calculations: 49483-623-50
1000 calculations: 49483-623-10
Metformin hydrochloride extended-release tablets, USP 750 mg:
100 calculations: 49483-624-01
