Additional diabetes medication has been recalled over the potential presence of an impurity that exceeds the acceptable daily limit. The recall comes from Nostrum Laboratories and follows a growing number of similar recalls from the past few months. Earlier this year, the FDA had published an editorial warning that some lots of metformin extended-release medication contained concerning levels of n-nitrosodimethylamine (NDMA).
The new Metformin HCl Extended Release Tablets recall comes from Nostrum Laboratories in Kansas City. The FDA recently highlighted the recall, which was voluntary and covers two lots of the medication made available to consumers in 750mg strength.
As with multiple other recalls this year, this recall is due to the potential presence of NDMA, an environmental contaminant that is found in a variety of foods, as well as water. This contaminant is difficult to avoid, but its status as a probable human carcinogen means the FDA has put a cap on how much NDMA consumers can be exposed to at 96 ng per day.
The company is advising consumers who are in possession of these drugs to return them to the pharmacy from which they were purchased. As with past recalls, consumers are likewise advised to talk to their doctors about getting a replacement rather than stopping the drug immediately — this is due to the risk of uncontrolled blood sugar.
Back in May, the FDA issued an advisory alerting doctors and the public to testing results that found unacceptably high levels of NDMA in some lots of metformin extended-release tablets. At the time, the agency said that it had been in contact with five firms seeking a voluntary recall of the drugs.
FDA Center for Drug Evaluation and Research acting director Patrizia Cavazzoni, MD, said at the time:
Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.
The recalled drug’s lot numbers, NDC, and expiration details can be found on the FDA’s website here.