SILVER SPRING, Md., May 28, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration is announcing today that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency's acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products. Company recall notices will be posted on FDA's website. There are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled. The FDA is continuing to work closely with manufacturers to ensure appropriate testing. Assessments are underway to determine whether metformin ER recalls will result in shortages and the agency will work closely with manufacturers to prevent or reduce any impact of shortages.
The Food and Drug Administration is contacting certain drug companies that make extended-release versions of metformin, the popular diabetes medication, after the agency found pills contaminated with a chemical known to cause cancer.
The US Food and Drug Administration (FDA) on Wednesday requested that all manufacturers of drugs containing ranitidine (commonly known as Zantac and used for heartburn) remove all prescription and over-the-counter (OTC) versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures.
Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine
FDA warns of carcinogen found in diabetes drugs outside of US
After NDMA contamination is found by Singaporean authorities, both the FDA and EMA state they are working on the testing of metformin treatments.
Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
Both companies issue a voluntary recall of their ranitidine-based products due to the ongoing investigation into cancer-causing contamination.
India’s Aurobindo, which has been racking up FDA actions right and left, acknowledged Monday a recent agency inspection resulted in a Form 483.
The FDA upended the entire landscape for makers of sartan-based blood pressure medicines after finding some contained potential carcinogens. Now, the FDA is trying a new tack.