Important recall notice Metformin Extended Release 750mg Recall – Nostrum Laboratories, Inc.

Updated: 1/26/21

On November 2, 2020, Nostrum Laboratories, Inc announced a voluntary recall of 2 lots (MET200101, Exp 5/2022 and MET200301 Exp 5/2022) and expanded with additional lots on January 4, 2021 (MET200501 Exp 7/2022) and January 25, 2021 (MET200601 Exp 7/2022) of Metformin Hydrochloride Extended-Release Tablets, USP 750mg. These lots were found to contain levels of NDMA, an unexpected impurity, at levels in excess of acceptable limits. Nostrum Laboratories has not received any reports of adverse events related to this recall.

Patients who have confirmed receipt of a recalled lot should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Patients with additional medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

What do I need to know?

• Express Scripts will notify patients who have received medication impacted by the recall.
• Please be aware that your home delivery pharmacy is not able to accept returns or credit your account for the recalled drug product.
• The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider, as the risk of harm to the your health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy.
  • If you and your prescriber decide you should continue to take the medication on hand, your next fill will be processed using medication that is not part of any existing recall.
  • If you choose to stay on this therapy but need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.

Additional information is available on the FDA’s website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0