- A popular diabetes drug was just recalled because it may contain a cancer-causing agent at higher-than-normal concentrations.
- Metformin tablets sold under the brand name Time-Cap Inc., are being widely recalled.
- The FDA has a list of the product codes and other identifying information, so if you have any of these meds at home, contact your doctor immediately and arrange for replacement treatment.
If you struggle with chronic health issues like type 2 diabetes, you know how challenging it can be to just live a normal day-to-day life. Meds can help in a big way, and untold millions rely on medications to help them manage their conditions. However, drugs are only helpful if they’re both effective and safe, and a newly-expanded recall of a popular diabetes medication shows that the “safe” part can be somewhat hit-or-miss.
In a new company announcement posted by the FDA, a company called Marksans Pharma Limited announces the expanded recall of its metformin hydrochloride extended-release tablets. The drugs are prescribed for the management of diabetes, but these tablets may be tainted with unacceptably high levels of NDMA, or N-Nitrosodimethylamine, a likely human carcinogen.
The initial recall of the drug was announced way back in early June of this year, but after additional investigation, it became clear that more lots of the drug may have been contaminated with high levels of NDMA. The company’s statement reads in part as follows:
Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (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.
NDMA is a contaminant that is found in many foods and even water. It’s considered a probably human carcinogen, which means it likely promotes the odds of cancer development. However, it’s considered to be relatively safe in light concentrations. The issue for Marksans Pharma Limited is that its pills were shown to have an elevated level of the carcinogen, which is unacceptable for sale based on U.S. regulations.
The FDA’s official bulletin includes a full list of the products and lot numbers, ranging from 1,000-count packs of 500 mg tablets to 100-count packs of 750mg tablets. The lot numbers and product codes are also included. The pills were sold under the brand name Time-Cap Labs Inc., so if that sounds familiar and you have some of these pills sitting in your medicine cabinet, you should contact your doctor immediately to see how to proceed.
It’s unsafe to simply stop taking this medication without having an alternative lined up, so make sure you speak to your doctor and get another prescription before tossing these potentially tainted pills in the trash.