October 06, 2020
On June 5, 2020, Marksans Pharma voluntarily recalled a single lot of Metformin Hydrochloride Extended-Release Tablets, USP 500mg (Lot # XP9004), distributed by Time-Cap Labs Inc. On October 5, Marksans expanded the recall to include an additional 76 unexpired lots of the 500mg and 750mg strengths. These lots were tested and showed results for NDMA, an unexpected impurity, at levels in excess of acceptable limits and are being recalled out of an abundance of caution.
What do I need to know?
- Express Scripts has made attempts to contact all patients who were shipped an impacted order by phone, and will continue until all are impacted patients are reached.
- 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.
Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address email@example.com.
Additional information is available on the FDA’s website:
Last updated: October 06, 2020