Some batches of a diabetes drug sold by a Farmingdale company are being recalled after they were found to contain higher-than-normal levels of a known carcinogen, officials said.
The metformin hydrochloride extended-release tablets are being voluntarily recalled by manufacturer Marksans Pharma Ltd. of Mumbai, India. The generic prescription drug was found to contain more than the acceptable level of nitrosodimethylamine, which can cause cancer, according to the officials.
The tablets are sold to U.S. pharmacies via Time-Cap Labs Inc., located across from Farmingdale’s Republic Airport. The local company, which also goes by Time Cap Labs, is a subsidiary of Marksans, Meena Rani, vice president of regulatory affairs and compliance, said Monday night.
The recalled tablets, which are 500 and 750 milligrams each, are used to treat type 2 diabetes. The tablets are white or off-white with 101 or 102 stamped on the side. Seventy-six lots are affected.
More information about the recall may be found at nwsdy.li/recall.
This is Marksans’ second recall of metformin hydrochloride extended-release tablets. In June, the company issued a recall for a single lot of 500 mg tablets marked with 101 on the side.
Marksans "has not received any reports of adverse events that have been related to this recall," the company said earlier this month.
"Consumers taking this recalled product … should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option," Marksans said. "It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional."
At least seven other manufacturers have issued recalls of metformin hydrochloride extended-release tablets.
Marksans purchased Time-Cap five years ago for $28 million from founder and CEO Joseph Errigo.
Marksans CEO Mark Saldanha said at the time, "This strategic acquisition helps Marksans expand its manufacturing capabilities along with product portfolio and penetration into the U.S."
Time-Cap had sales of $30 million in 2014 and a work force of about 150 people.