The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.
A pharma maker is expanding its earlier recall of metformin due to a higher content of the carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than is allowed.
Marksans Pharma Limited in India is voluntarily expanding its earlier initiated recall in June to include an additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg. and 750 mg. to the consumer level.
“Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96 ng/day. Therefore, out of an abundance of caution, an additional 76 lots are being recalled,” the pharma maker said in a press release.
Several pharmaceutical manufacturers have recalled metformin in recent months due to the presence of NDMA. FDA said in a press release in June that its testing found “certain extended release metformin products contain NDMA above the acceptable level.”
Late last month, Sun Pharmaceuticals recalled 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg. per 5 mL to the consumer level.
In the Marksans recall, the recalled metformin was distributed by Time-Cap Labs in New York, nationwide to wholesalers that further distributed the medication to pharmacies.
Marksans is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement of recalled product lots.
Read more: Major metformin recalls underway