The tablets are either embossed with 101 or 102 on one side and are plain on the other.
(undated) – The widely-used diabetes drug Metformin has been recalled after manufacturers have found it contained unacceptably high levels of cancer-causing contaminants.
According to WDRB, Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets due to its levels of NDMA, a “probable human carcinogen,” which were higher than the acceptable daily intake limit of 96 nanograms per day, according to a recall by the U.S. Food and Drug Administration.
Individuals with type 2 diabetes use metformin to help lower glucose levels.
This recall applies to metformin tables that are 500 mg and 750 mg, which are sold under that brand name Time-Cap Labs Inc.
This recall expands from an earlier recall of the same product from this summer, but it’s just one of several metformin products that have been found to contain higher levels of NDMA in the last year.
Accoding to WDRB, the recall applies to the following products, which can be identified by their National Drug Code numbers listed below (National Drug Codes can be used to search and identify products online through the FDA). The tablets are either embossed with 101 or 102 on one side and are plain on the other.
Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01
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