The recall of metformin, a diabetes-control drug popular in the U.S. market, has expanded because of the presence of an impurity that could increase the risk of cancer. The expanded recall is for Marksans Pharma Ltd., which covers the brand name Time-Cap Labs. A total of two drugs of varying intensity have been recalled, but the company says patients should not stop taking recalled drugs immediately, even during the recall process, in order to keep the condition under control.
The latest recall notice covers a large number of metformin HCL slow-release tablets, valid from October 2020 to April 2022. These products are sold in 90 to 1000 tablets with contents of 500mg and 750mg.
The FDA provides a list of all newly recalled metformin products, including their UPC codes and other identification details.
The reason for the expanded recall, which covers a total of 76 unexolvaged drugs, is based on what we’ve heard before that the tablet may contain an overly high level of impurities called N-nitrodymphetamine (NDMA), which has been identified as a potential carcinogen in humans.
Since NDMA is present in water and food, it is not possible to avoid it entirely; however, it is classified as a possible carcinogen, meaning that there is a limit to the amount that a person can take daily medication, which is currently 96ng per day. Some drug recall processes in the past have also involved potentially high levels of this NDMA impurity present in metformin drugs.
As with previous metformin recalls, patients who are currently taking one of these recalled products are warned to continue taking the drug while waiting for an alternative from their doctor or pharmacist – the risk of uncontrolled blood sugar is greater than the risk of exposure to possible carcinogens, and customers are advised to return the recalled drug to the store where they purchased it.