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Marksans Metformin Extended Release Recall Issued Due To High Levels of NDMA

Problems with high levels of the cancer-causing chemical N-Nitrosodimethylamine (NDMA) contaminating metformin pills has resulted in another recall for extended release versions of the generic diabetes drug.

On October 5, the FDA announced a Marksans Pharma Limited Metformin recall expansion involving 76 lots of extended release tablets of 500mg and 750mg strength. It is an expansion of a prior recall issued in early June, involving pills sold by Time-Cap Labs Inc.

NDMA is considered a human carcinogen, which can be a byproduct of the drug manufacturing process or produced as an inherent byproduct of certain pharmaceutical ingredients.

In recent years, detection of the chemical has resulted in widespread Zantac recalls and valsartan recalls, and users of the popular heartburn and blood pressure medications have reported developing various types of cancer following long-term use, including breast cancer, bladder cancer, stomach cancer, testicular cancer and other injuries.

This latest recall impacts Metformin Hydrochloride Extended Release Tablets, USP 500 mg, in 90-count bottles with NDC number 4948362309, 100-count bottles with NDC number 49483-623-01, 500-count bottles with NDC number 49483-623-50, and 1,000-count bottles with NDC number 49483-623-10. In addition, the recall also includes Metformin Hydrocholride Extended-Release Tablets, USP 750 mg in 100-count bottles with NDC number 49483-624-01.

The recalled metformin tablets are white to off=white, capsule shaped, bi-convex tablets. The 500 mg tablets are debossed with “101” on one side, and the 750 mg tablets are debossed with “102” on one side. The other side of both types of tablets are plain. A complete list of lot numbers is available in the recall notice.

The tablets were manufactured by Marksans Pharma Limited, of India, and distributed by Time-Cap Labs, Inc, in Farmingdale, New York.

Marksans and the FDA recommend consumers who have the recalled pills keep taking them until a doctor or pharmacist supplies a replacement or a different treatment, due to the potential risks of type 2 diabetes.

Consumers with questions about the recall can contact Irene McGregor, vice president of regulatory affairs for Time -Cap Labs, by calling 631-753-9090, ext. 160, or by e-mail at imcgregor@timelabs.com.

Metformin NDMA Problems

In December 2019, reports first warned about the potential risk of metformin NDMA contamination problems, after some versions of the drug sold outside the United States tested positive for the chemical, raising concerns that metformin recalls may be necessary. However, the FDA indicated at the time that testing of products distributed in the U.S. found that the NDMA levels in metformin were undetectable or below federal limits for exposure to the chemical.

In March 2020, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to recall metformin, after independent testing found levels of NDMA in certain pills was higher than the agency’s recommended daily exposure threshold of 96 nanograms.

Since then, the FDA says it has confirmed some of the Valisure findings, resulting in a number of separate recalls as specific lots of the medication have been found to contain higher than acceptable levels of NDMA.

Since the metformin recalls began, a number of consumers have filed NDMA lawsuits against manufacturers of the generic drugs, indicating they developed cancer from the tainted diabetes medication.

The FDA requests any healthcare providers or consumers who experience adverse reactions or quality problems when using the affected drugs report the incident to the FDA MedWatch Adverse Event Reporting program.

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