Metformin Extended Release 500mg – Marksans Pharma / Time-Cap Labs

June 08, 2020

After notification of any recall, Express Scripts will continue processing new and refill prescriptions with product from non-recalled lots or manufacturers, if available.

Express Scripts did NOT dispense any lots impacted by this recall.

Marksans Pharma is voluntarily recalling a single lot of Metformin Hydrochloride Extended-Release Tablets, USP 500mg (Lot # XP9004), distributed by Time-Cap Labs Inc. Marksans was notified by the U.S. Food and Drug Administration that this lot was tested and showed results for NDMA, an unexpected impurity, at levels in excess of acceptable limits.

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 imcgregor@timecaplabs.com.

Additional information is available on the FDA’s website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release

Last updated: July 14, 2020

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