Another batch of diabetes drugs has been recalled because of the possibility of impurities that exceed daily acceptable limits,media reported. The recall comes from Nostrum Labs, which has seen several similar recalls in the past few months. Earlier this year, the U.S. Food and Drug Administration (FDA) issued an editorial warning that some batches of metformin-relieving drugs contained high levels of N-nitrodiformamine (NDMA).
The new metformin HCl slow-release tablets are recalled from The Nostrum Lab in Kansas City. The FDA recently stressed that the recall is voluntary and covers two batches of 750mg of the drug, which are available to consumers.
As with several other recalls this year, the reason for the recall is the possible presence of NDMA, an environmental pollutant found in a variety of foods and water. The pollutant is unavoidable, but as a possible human carcinogen, the FDA has capped the amount of NDMA consumers can earn per day at 96 nark.
The company recommends that consumers who hold these drugs return them to the pharmacy they purchased. As with past recalls, consumers are also advised to talk to their doctors about changing drugs, rather than stopping them immediately — because of the risk of runaway blood sugar.
As early as May, the FDA issued an announcement alerting doctors and the public to the test results because it found unacceptable levels of NDMA in some batches of metformin. At the time, the agency said it had contacted five companies seeking voluntary recalls of the drugs.
Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said at the time:
Now that we have identified some metformin products that do not meet our standards, we are taking action. Since this impurity was first discovered, we have been doing it, we will communicate when new scientific information is available, and we will take further action, if appropriate.
Details of the batch number, NDC and expiration date of the recalled drug can be found on the FDA’s website.