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Drug Safety Alerts
Lupin Metformin Hydrochloride Extended-Release Consumer-Level Recall
7/17/2020
On July 17, 2020, Lupin Pharmaceuticals, Inc. issued a consumer-level recall of all of its Metformin Hydrochloride Extended-Release 500 mg and 1000 mg tablets. Lupin advised that 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 the impurity N-Nitrosodimethylamine (NDMA) and that 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. Lupin further advised that to date it has not received any reports of adverse events related to this recall.
NDMA is classified as a probable human carcinogen based on laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Metformin is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients taking recalled Metformin Hydrochloride Extended-Release 500 mg tablets and 1000 mg tablets are advised by the FDA to continue taking their medication and contact their health care professional who can prescribe a replacement. According to the United States Food and Drug Administration (FDA) it could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professionals.
A complete list of the products included in this recall is provided here.
CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Metformin Hydrochloride Extended-Release 500 mg and 1000 mg tablets to contact their prescriber.
For more information, call Inmar Rx Solutions, Inc. by phone at 1- 855-532-1856, Monday - Friday, 9:00 am – 5:00 pm, EST. You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.