Nostrum Laboratories, Inc. Metformin HCl Extended Release Tablets, USP 750 mg - recalled due to Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day, USA

United States

Company name: Nostrum Laboratories, Inc.
Brand name: Nostrum Laboratories, Inc.
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day
FDA Recall date: January 25, 2021
Recall details: Kansas City, Missouri,Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2nd 2020. 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. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide in the USA to wholesalers who further distributed to pharmacies and patients.

- Product Description: Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)
- NDC: 29033-056-01
- Lot Number: MET200601
- Expiry Dates: 07/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0

Source: FDA