Metformin Extended Release 7500mg Recall – Granules Pharmaceuticals Inc.

Major Pharmaceuticals is voluntarily recalling a single lot of Metformin Hydrochloride Extended-Release Tablets, USP 500mg. This lot (Lot#: T-02134, Expiration 09/30/20) was tested and showed results for NDMA, an unexpected impurity, at levels in excess of acceptable limits. Major has agreed to recall this lot.

What do I need to know?

• 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.

Why was this medication recalled?

• This voluntary recall is being issued by Major working with the FDA because an impurity N-Nitrosodimethylamine (NDMA) was detected in the identified lot.
• 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: https://www.fda.gov/MedWatch/getforms.htm. Mail to the address on the pre-addressed form.
• Fax: 1-800-332-0178 (toll free)