FDA – According to an FDA Recall Update, Nostrum Laboratories, Inc. expended its nationwide recall of its Metformin HCl Extended-Release Tablets, USP 750 mg, on January 25, 2021. The reason for the recall is due to the unsafe, higher than Acceptable Daily Intake (ADI) amount of N-Nitrosodimethylamine (NDMA). The maximum allowable limit of nitrosamine impurities is 96 ng or less per day.
Nostrum Laboratories, Inc. is a pharmaceutical company based out of Kansas City, Missouri. On January 25, 2021, the company announced that the company is extending its recall of one lot of Metformin HCl Extended-Release Tablets, USP 750 mg (a Glucophage Tablet generic equivalent). These metformin tablets contained unsafe levels of nitrosamine impurities, which are known carcinogens to humans. This is an expansion to the existing recall initiated on November 2, 2020.
N-Nitrosodimethylamine (NDMA) is a naturally occurring substance that is found in foods and water. NDMA is an environmental contaminant that is listed as a known human carcinogen. As of this report, Nostrum Laboratories, Inc. has not received any adverse event reports associated with this recall. However, metformin is a medication manufactured by dozens of pharmaceutical companies.
The recalled product was packaged in HDPE bottles of 100 metformin tablets, filed under National Drug Code (NDC) 29033-056-01. The tablet is identifiable as an “off-white, oblong tablet” with a debossed “NM7” on one side of the tablet. Metformin HCl Extended-Release Tablets, USP 750 mg was distributed throughout the United States to wholesalers who sold the medications to pharmacies and patients.
|Product Description||NDC||Lot Number||Expiry Dates|
|Metformin HCl Extended Release Tablets, USP 750 mg||29033-056-01||MET200601||07/2022|
Nostrum Laboratories, Inc. is contacting all distributors by letter and will prepare arrangements for the return of the recalled products. Pharmacies that have the recalled metformin should return the medications to the original place of purchase. Consumers prescribed the recalled metformin should speak to their healthcare professional to receive a replacement or alternative medicine. Patients with type 2 diabetes should not stop taking their metformin due to severe complications. Patients should speak with their doctor if they have endured any difficulties related to this recalled medication.
This recall of Metformin HCl Extended-Release Tablets, USP 750 mg, is being administered with the U.S. Food and Drug Administration knowledge. The following is a link to the Initial Recall. The following link displays the First Expanded Recall.
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