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Extended-release metformin tablets recalled due to dangerous levels of NDMA

Marksans Pharma Limited, based out of India, is recalling their 500 mg and 750 mg metformin tablets sold under the brand name Time-Cap Labs, Inc. The recalled medication was found to contain dangerous levels of the suspected cancer-causing human carcinogen N-Nitrosodimethylamine (NDMA). These types of medications are used to treat type 2 diabetes and help lower glucose levels.


Recalled Products:

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


The National Drug Codes for the recalled products are posted above, and they can also be identified by the numbers on the actual tablets, 101 or 102. In a not totally surprising move, Marksans Pharma did not reveal the NDMA levels in their medications that forced the recall.  96 nanograms is the daily limit of N-Nitrosodimethylamine. The limit is this low for a reason. NDMA is classified by the U.S. Food and Drug Administration as a “probable human carcinogen”. 

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