The number of type 2 diabetes drugs recalled due to high levels of a probable cancer-causing impurity continues to climb. This week, Marksans Pharma Limited announced it was expanding a recall of its Metformin Hydrochloride Extended-Release Tablets after testing revealed 76 unexpired lots contained excessive amounts of N-Nitrosodimethylamine (NDMA), the same impurity that was found in the heartburn drug Zantac, which was pulled off the market in April due to public health concerns.
The recall includes 500mg tablets in 90-, 100-, 500-, and 1,000-count bottles and 700mg tablets in 100-count bottles. A full list of Marksans Pharma’s recalled metformin with NDC and Lot numbers can be found on the company’s news release.
Metformin extended-release tablets are used along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
In September, the Food and Drug Administration (FDA) announced guidance for manufacturers of active pharmaceutical ingredients and drug products to detect and prevent concerning levels of NDMA and other so-called nitrosamine impurities in their pharmaceutical products.
Concerns over NDMA in pharmaceutical drugs began in 2018 when testing revealed elevated levels of NDMA in high blood pressure and heart failure treatments known as ARBs. The problem was linked to contamination during the manufacturing process.
A year later, the same contaminant was found in Zantac and other heartburn drugs containing the active ingredient ranitidine. What is unusual about the NDMA in Zantac is that it appears to increase over time even under normal storage conditions, such as when exposed to higher temperatures or is farther in time from its manufacture date.
Attorneys with Beasley Allen Law Firm are currently investigating claims of those who have used Zantac, which was voluntarily recalled from the market on Sept. 13, 2019, and withdrawn on April 1, and has been linked to certain types of cancer, including liver, bladder, stomach, colon, kidney and pancreatic cancer. If you or a loved one was a regular user of Zantac and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims.