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Honored Contributor
Posts: 8,059
Registered: ‎05-23-2010

Another Metformin recall. Nostrum Labs expands previous recall.

[ Edited ]
Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Summary
Company Announcement Date: January 25, 2021 FDA Publish Date: January 25, 2021 Product Type: Drugs Reason for Announcement:
Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day
Company Name: Nostrum Laboratories, Inc. Brand Name:
Nostrum Laboratories, Inc.
Product Description:
Metformin HCl Extended Release Tablets, USP 750 mg

Company Announcement

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 DescriptionNDCLot NumberExpiry Dates
Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)29033-056-01  
MET20060107/2022

Nostrum Laboratories, Inc.  is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

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.

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
  • Regular Mail or Fax: Download form 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.

Link to Initial Recall

Link to First Expansion


Company Contact Information
Consumers: Nostrum Laboratories, Inc. Medical Affairs 816-308-4941 quality@nostrumpharma.com
Honored Contributor
Posts: 8,302
Registered: ‎03-09-2010

Re: Another Metformin recall. Nostrum Labs expands previous recall.


@Mindy D 

 

Thank you for posting.  My nephew who currently has Covid and who is quite ill takes Metformin because the insurance he has will only allow that.  He has been diabetic for quite sometime and according to his doctor, should be on insulin, but he has the insurance that will not pay for it.  In fact, all his medicines cost him a fortune and he has a huge deductible, like $5000/year.