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 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.
Neither the FDA notice nor Marksans' release disclosed 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.
The FDA has recently published a running list of the recalls for each metformin product.
Since then, however, the recalls have expanded to drugmakers outside the original scope of the investigation.
Late last month, Sun Pharma recalled one lot of its Riomet ER, an extended-release version of the common diabetes med, after finding high NDMA levels.The recalled lot contained 747 bottles of the drug with an expiration date of October 2021, Sun said in a release.
Sun was the seventh drugmaker to launch a voluntary recall of its version of metformin after the FDA earlier this year found high levels of NDMA, a contaminant connected to global recalls of "sartan"-based heart pressure drugs and heartburn med Zantac, in tested lots.
In August, New Jersey-based Bayshore Pharmaceuticals recalled one lot each of its 500- and 750-milligram extended-release metformin after the FDA found high levels of NDMA in tested samples.
Before that, Lupin Pharmaceuticals in July pulled all lots of its extended-release metformin after discovering high levels of NDMA in sample lots. Just days earlier, the FDA had said Virginia-based Granules Pharmaceuticals would pull its own version of extended-release metformin based on the same contamination concerns.