Nostrum Recalls More Lots of its Metformin Due to Nitrosamine Contamination Risks
WASHINGTON D.C. – According to an endpts.com article, Nostrum Laboratories, Inc. has expanded its generic Metformin recall due to possible nitrosamine contamination. Nitrosamines are organic chemicals that can be created during a chemical reaction in the drug manufacturing process. According to the FDA, extended exposure to nitrosamines can increase a person’s risk of developing cancer. Nostrum Laboratories, Inc. has previously recalled other generic metformin drugs over the past several months.
According to the FDA’s recall notice, Nostrum Laboratories, Inc. has recalled one lot of its Metformin HCl extended release tablets, USP 750 mg. The affected lot is numbered MET200501, and has an expiration date of July 2022. This type 2 diabetes medication is the generic equivalent of Glucophage tablets.
This Metformin HCl extended release tablet recall is an expansion of the company’s previous Metformin recall initiated in November of 2020. This recall is for the same drug and for the same issue. However, the last recall only affected the 500 mg Metformin HCl extended release tablets.
Our law firm reported on this recall back on November 14, 2020.
The FDA advises all patients taking metformin to consult their prescribing physician before they discontinue use of the medication to avoid dangerous complication.
This expanded Metformin recall is part of a massive Metformin recall affecting at least eight manufacturers throughout the world. The U.S. Food and Drug Administration manages a list of all Metformin drugs that are being recalled here.
According to the FDA, drug manufacturers are responsible for the manufacturing processes. Drug manufacturers have an obligation to prevent dangerous impurities from contaminating their medications. The FDA has released processes and testing methods to help manufacturers prevent and detect nitrosamine impurities.
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