The FDA has expanded a recall of a highly prescribed diabetes drug that may contain high levels of a cancer-causing agent.
Metformin hydrochloride extended-release tablets, 500mg, & 750mg, was originally recalled in June, after it was found to contain higher-than-normal levels of a known carcinogen, the FDA said.
In the new recall, an additional 76 lots of the drugs have been recalled. The original metformin drug that is not time-released is not included in the recall.
The original recall was initiated after it was found the drug contained unsafe levels of nitrosodimethylamine, which can cause cancer, according to the FDA.
The pills, which are made by manufacturer Marksans Pharma Ltd. of Mumbai, India, are sold in the United States through Time-Cap Labs Inc., located on Long Island in Farmingdale.
The company is a subsidiary of Markson's.
The medicine is used to treat type 2 diabetes, along with diet and exercise, by improving blood glucose control.
The affected pills include 500mg, which are white to off white, capsule-shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side, and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, which are white to off white, capsule-shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.
The Farmingdale company is notifying distributors and customers by issuing notification letters and with a press release and is arranging for return/replacement etc. of recalled product lots.
Consumers with questions regarding this recall and return can contact Ms. Irene McGregor of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, Monday to Friday 8 a.m.-5 p.m. or e-mail address email@example.com.
Consumers taking these recalled products should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option.
It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional, the FDA said.
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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