In the months since the FDA identified a probable carcinogen in tested lots of generic diabetes med metformin, the list of companies pulling their versions off U.S. shelves has continued to grow. Now, an Indian firm is dramatically expanding an earlier recall to include a vast swath of its version of the drug.
India’s Marksans Pharma yanked (PDF) an additional 76 lots of its version of generic diabetes med metformin off U.S. shelves after finding high levels of probable carcinogen N-nitrosodimethylamine (NDMA) in more sampled lots, the company said.
The expansive recall includes 90-, 100-, 500-, and 1,000-count bottles of two different strengths of Marksans’ extended-release version of the drug, the FDA said in a notice published online Monday. The unexpired pills were distributed by Time-Cap Labs.
Both the FDA notice and Marksans’ release did not disclose the number of bottles affected by the recall. Marksans said it intends to continue manufacturing its version, which pulled in $1.43 million in sales in the year ending March 31, with “proactive” measures in place.
A Marksans spokesperson could not be reached for comment.
Back in June, Marksans initially recalled a single lot of the 500-milligram dose of its metformin at the request of the FDA, which identified high levels of NDMA in versions of the med made by five drugmakers. The others were Lupin, Apotex, Teva, and Amneal.