Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets designed to lower glucose levels because their levels of NDMA, a “probable human carcinogen,” were higher than the acceptable daily intake limit of 96 nanograms per day. The recall applies to metformin tablets between 500 mg and 750 mg, sold under the brand name Time-Cap Labs, Inc. The FDA is still investigating where NDMA comes from and how it ends up in metformin products.
The recall applies to the products which can be identified by their National Drug Code numbers listed. For 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. For Metformin Hydrochloride Extended-Release Tablets, USP 750mg: 100 counts: 49483-624-01. Metformin is the first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight. It was discovered in 1922 and introduced as a medication in France in 1957 and in the United States in 1995. In 2017 it was the fourth-most commonly prescribed medication in the United States, with more than 78 million prescriptions.