Two additional manufacturers have issued voluntary recalls of a popular diabetes drug after determining it contained unacceptably high levels of a cancer-causing agent.
Marksans Pharma Ltd. and Sun Pharmaceutical Industries Ltd., both based in India, joined at least eight other companies in voluntarily recalling extended-release metformin since the issue was first detected by the U.S. Food and Drug Administration in May.
According to the Mayo Clinic, metformin is used to treat type 2 diabetes and is distributed under the following brand names: Fortamet, Glucophage, Glucophage XR, Glumetza and Riomet.
The FDA issued an alert in May stating agency laboratory testing of several lots of extended-release metformin revealed levels of N-Nitrosodimethylamine, known as NDMA, that exceeded the agency’s acceptable limits, USA Today reported.
“We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in the May 28 release.
Marksans Pharma and Sun Pharmaceutical join the following companies on the list issuing recalls:
• Amneal Pharmaceuticals
• Apotex Corp.
• AVKARE Inc (Amneal)
• Bayshore Pharmaceuticals LLC
• Granules Pharmaceuticals
• Lupin Pharmaceuticals
• PD-Rx Pharmaceuticals (Amneal)
• PD-Rx Pharmaceuticals (Marksans)
• Teva Pharmaceuticals
The FDA also noted in its May release that NDMA has not been found in the most commonly prescribed variety of metformin, the immediate release products.
The current recall applies to metformin tablets between 500 mg and 750 mg, sold under the brand name Time-Cap Labs Inc.
According to CNN, the recall applies to the following products, which can be identified by their National Drug Code numbers listed alongside the product names.
Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
• 90 counts: 49483-623-09
• 100 counts: 49483-623-01
• 500 counts: 49483-623-50
• 1000 counts: 49483-623-10
Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
• 100 counts: 49483-624-01
Cox Media Group