October 2, 2020

Marksans Pharmaceuticals has voluntarily expanded its June 5, 2020, recall of Metformin Hydrochloride Extended-Release (ER) Tablets, USP 500mg and 750mg, to include an additional 76 unexpired lots. The recall is due to testing that showed these additional lots may contain the probable carcinogen (cancer-causing agent) N-nitrosodimethylamine (NDMA) in excess of the U.S FDA’s acceptable daily intake limit of 96ng per day.

NDMA is a known environmental contaminant found in sources such as food and water. It has also been identified in several medications, including certain lots of metformin ER, ranitidine, and angiotensin II receptor blockers (ARBs or “sartan” drugs).

Metformin ER is indicated as an adjunct to diet and exercise to improve blood sugar control in adults who have type 2 diabetes mellitus. Because the risk of stopping the medication may be higher than the risk of taking it, the FDA advises patients to continue their metformin ER and speak to their prescriber or pharmacist about treatment options. If a patient experiences any problems that may be related to use of the medication, they should notify their healthcare provider. Adverse events can also be reported to the FDA’s MedWatch program.

For questions regarding the recall, consumers should contact Ms. Irene McGregor, Vice President, of Regulatory Affairs at Time-Cap Labs, Inc., by phone at 1-631-753-9090, extension 160, or by email at imcgregor@timecaplabs.com.

The full recall announcement, including affected lot numbers, can be viewed on the FDA’s website.

There is no impact to members through Benecard Central Fill.

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