July 08, 2020
On June 11, 2020 Lupin Pharmaceuticals is voluntarily recalling a single lot of Metformin Hydrochloride Extended-Release Tablets, USP 500mg (Lot G901203, Expiration December 2020). On July 8, 2020 Lupin announced that it was voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg within expiry. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for NDMA, an unexpected impurity, at levels in excess of acceptable limits and recommended recall of the additional lots out of an abundance of caution.
Additional information is available on the FDA's website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended
What do I need to know?
- Express Scripts will notify 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.
- Please be aware that your home delivery pharmacy is not able to accept returns or credit your account for the recalled drug product. If you have Metformin ER distributed by Lupin, you can contact Lupin's product recall processor, Inmar Rx Solutions to arrange return and/or credit: Inmar Rx Inc. Monday - Friday 9:00 am to 5:00 pm EST at (855) 532-1856 to request a product return and reimbursement packet.
Why was this medication recalled?
- This voluntary recall is being issued by Lupin working with the FDA because an impurity N-Nitrosodimethylamine (NDMA) was detected in certain lots. Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US.
- 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)
Last updated: July 14, 2020