(RxWiki News) The US Food and Drug Administration (FDA) is alerting the public about additional voluntary recalls of certain metformin products.
The FDA has notified patients about higher-than-acceptable amounts of a possible cancer-causing impurity in specific metformin-containing products.
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 possibly cause cancer.
These two voluntary recalls are for extended-release (ER) metformin products manufactured by Marksans Pharma and Sun Pharmaceutical Industries.
In May of this year, several companies issued a voluntary recall for specific metformin tablets. One of those companies was Marksans.
Now, Marksans Pharma Limited, India, is recalling an additional 76 lots of metformin extended-release tablets (500 mg and 750 mg).
Furthermore, Sun is voluntarily recalling one lot of its metformin extended-release oral suspension (500 mg per 5 mL), which is found under the name Riomet ER.
Metformin is a common medication used to treat high blood sugar in patients with type 2 diabetes.
The FDA recommended that consumers continue to take their medication as directed and ask their pharmacist 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 agency also recommended that consumers contact their health care provider if they experience any problem they believe may be linked to this medication.
Speak with your pharmacist if you have any questions.