According to a new report by the FDA, Nostrum Laboratories has expanded its recall of Metformin HCI tablets. Metformin HCI extended-release tablets, generic Glucophage tablets, were found to have levels of N-Nitrosodimethylamine (NDMA.) NDMA is classified as a probable human carcinogen based on test results. NDMA is a known environmental contaminant and is found in food and water. However, the FDA guidelines limit the daily intake of this substance.
Metformin is a product used, along with diet and exercise to help improve a patient’s glucose control for those with type 2 diabetes. The affected bottles have been packaged in HDPE bottles of 100 tablets. They are under the id of NDC 29033-056-01 and have the lot number of MET200501. Affected bottles have an expiration date of 07/22. According to the FDA, Nostrum is notifying distributors to arrange for the return of all recalled products. Those with the affected products are advised to consult with a healthcare professional to obtain a replacement medication or different treatment option. It could be dangerous for patients to suddenly stop taking their Metformin without talking to their primary physician.
If you have experienced any problems that may be related to this drug, you should contact your healthcare provider immediately.
Consumers with medical questions regarding the recall can contact Nostrum’s medical affairs office at 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 a.m to 5 p.m. CT. A full list of recalled Metformin can be found here.
Visit the FDA’s recall notice on its website for more information.
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