Following an initial recall in June, Marksans Pharma Limited has now issued an expanded recall for its Metformin Hydrochloride extended-release tablets because they may contain N-Nitrosodimethylamine (NDMA) – a possible cancer-causing ingredient – in levels higher than acceptable by the U.S. Food and Drug Administration (FDA).
Metformin Hydrochloride tablets are used for blood glucose management in adults with Type 2 diabetes. The affected Metformin is one of several diabetes drugs that have been recalled in recent months for higher than acceptable levels of NDMA.
In this recall, the medication was distributed nationwide by Time-Caps Labs Inc. The recall affects 76 lots of the medication sold in 500 mg and 750 mg dosages. The affected Metformin was packaged in high-density polyethylene bottles in 90, 100, 500, and 1,000 counts.
In the 500 mg dosage, the Metformin has an NDC number of 49483-623-09 (90-count), 49483-623-01 (100-count), 49483-623-50 (500-count), and 49483-623-10 (1,000-count). In the 750 mg dosage the drug has an NDC number of 49483-624-01 (1,000-count).
The 500 mg Metformin tablets are white to off-white in color and have capsule-shaped biconvex tablets with “101” debossed on one side. The other side is plain. The 750 mg Metformin tablets are white to off-white, capsule-shaped, biconvex tablets with “102” debossed on one side. The other side is also plain.
A full list of recalled Metformin tablets and medication labels can be viewed here.
Consumers that have the recalled metformin medication in their possession should return it to the place of purchase. Questions about the recall can be directed to Irene McGregor, vice president of regulatory affairs at Time-Cap Labs by phone at 1-631-753-9090, ext 160, Monday through Friday from 8 a.m. to 5 p.m. EDT or by email at [email protected]
Consumers that are currently prescribed the recalled Metformin should continue taking their medication until their doctor or pharmacist provides a replacement or alternative treatment. It could be more dangerous for a patient to abruptly stop taking the medication without talking to their healthcare provider first. Problems related to the affected metformin drug should be discussed with a physician.
Marksans Pharma Limited said it has not received any reports of adverse reactions from the recalled drug.