A widely popular diabetes drug—metformin hydrochloride extended-release tablets—has been recalled after the manufacturers found a high level of the cancer-causing agent. It is Marksans Pharma Limited, an Indian pharmaceutical company, which is recalling the medicine for the unaccepted levels of N-Nitrosodimethylamine (NDMA)—a probable human carcinogen.
The US Food and Drug Administration (FDA) has said in a recently published statement that "Marksans performed NDMA testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled."
The drug is used to treat patients with type 2 diabetes. Metformin tablets are made to lower glucose levels in diabetic patients. The recall applies to the medicine between 500 mg and 750 mg that is sold under the brand name of Time-Cap Labs, Inc. However, there are seven other companies that have issued recalls for the metformin tablets because of their carcinogenic contents.
FDA is currently investigating NDMA impurity in metformin products. Even though most levels found in drugs are generally low and fall under FDA's regulations, in terms of the recent case the levels have exceeded the margin. As of now, the Indian pharmaceutical company did not release details about how much NDMA those recalled products contained.
As per FDA, some ranitidine drugs, including some products commonly known as the brand-name drug Zantac, include a nitrosamine impurity called NDMA (a substance that could cause cancer) at low levels.
It is a known environmental contaminant that can be found in water and foods, dairy products, including meats, and vegetables. The ongoing investigation related to NDMA and other nitrosamine impurities by FDA includes the analysis of blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.
Metformin Hydrochloride Extended-Release Tablets, USP 500mg, and USP 750mg are white to off-white, capsule-shaped, biconvex tablets. FDA said that the recall is applicable to the products which can be identified by their National Drug Code numbers listed here: