Lupin recalls Metformin Hydrochloride ER tablets in US over presence of NDMA Impurity

Baltimore: Drug major Lupin Ltd recently said it is voluntarily recalling its diabetes treatment drug Metformin Hydrochloride extended-release tablets in the US market.

The firm is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. 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).

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. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. The recalled NDC's are included in the table below:

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product NDC's.

Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency's website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Wholesalers, distributors, and retailers that have Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg that are being recalled should discontinue distribution of the recalled product NDC's immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 532-1856.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled NDC's returned to Inmar Rx Solutions, Inc.; the NDC number can be found on the top of the bottle label.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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