Impurities Found in Common Diabetes Rx Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) is alerting the public about an additional voluntary recall of certain extended-release metformin products.

The FDA is notifying patients about higher-than-acceptable amounts of a possible cancer-causing impurity in specific metformin-containing products.

Metformin is a common medication used to treat high blood sugar in patients with type 2 diabetes.

This notification is due to an impurity called N-Nitrosodimethylamine (NDMA). Based on results from laboratory tests, NDMA has been classified as a substance that could cause cancer.

In May of this year, the FDA issued a warning regarding this specific impurity. This warning involved five drug companies that issued a voluntary recall for specific lots of extended-release metformin tablets.

One of these companies was Lupin Pharmaceuticals Inc. However, back in May, only one lot of Lupin Pharmaceuticals Inc.’s metformin 500 mg tablets was part of the voluntary recall.

Now, Lupin Pharmaceuticals Inc. is issuing a voluntary recall for all of its batches of metformin hydrochloride extended-release tablets (500mg and 1000mg) due to an analysis that revealed that certain tested batches were above the acceptable daily intake limit of NDMA.

Lupin Pharmaceuticals Inc. has not received reports of adverse events regarding this recall, the FDA noted.

The FDA recommended that consumers continue to take their medication and ask their pharmacist, doctor or health care provider for an alternative treatment. Metformin treats high blood sugar, and stopping the medication without an approved replacement could be dangerous.

The FDA said it will continue to investigate this problem and provide more information as it becomes available.

The agency strongly encouraged consumers to report any issues with any of these products to its MedWatch Adverse Event Reporting program.

Speak with your pharmacist if you have any questions.


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