Safety Report: Metformin Hydrochloride Extended - recalled due to N-Nitrosodimethylamine (NDMA) Impurity, USA

United States

Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg
Reason of the recall: N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: July 08, 2020
Recall details: Lupin Pharmaceuticals Inc. 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:

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-338-01 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-339-09 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-336-07 / Distribution Dates: 11/05/2018 - 05/22/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-337-07 / Distribution Dates: 11/05/2018 - 05/22/2020

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 an 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.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended

Source: FDA