June 02, 2020
Amneal Pharmaceuticals is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg. Amneal was notified by the U.S. Food and Drug Administration that seven lots of Metformin Hydrochloride Extended-Release Tablets were tested and showed results for NDMA, an unexpected impurity, at levels in excess of acceptable limits and recommended recall of the seven tested lots. Amneal has agreed to recall these lots, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US.
To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
Additional information is available on the FDA’s website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
What do I need to know?
- Express Scripts will mail letters to patients who have received medication impacted by the recall.
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.
- It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for these recalled products.
Why was this medication recalled?
- This voluntary recall is being issued by Amneal working with the FDA because an impurity N-Nitrosodimethylamine (NDMA) was detected in the identified lots. Amneal has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution
- Any suspected adverse events that may be related to the use of these products should be reported to your doctor. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax.
- Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
- Regular Mail: Use postage-paid, pre-addressed Form FDA 3500B available at: www.fda.gov/MedWatch/getforms.htm. Mail to the address on the pre-addressed form.
- Fax: 1-800-332-0178 (toll free)
Last updated: August 28, 2020