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Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Due to detection of N-Nitrosodimethylamine (NDMA)

Company Name:
Teva Pharmaceuticals USA Inc.
Brand Name:

Brand Name(s)

Product Description:

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg


Company Announcement

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

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 is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

  • Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
  • Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.
NDCProduct DescriptionLot NumberExpiration
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1329548A06/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1338302M10/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1348968M10/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1348969M11/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1348970M10/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1376339M09/2021
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1323460M06/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1330919M06/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1338300A10/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1341135M12/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1391828M11/2021
62037-577-01Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count1333338M08/2020
62037-577-01Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count1333339A08/2020
62037-577-10Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count1354471A02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US 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. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at [email protected].

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

  • Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: [email protected].
  • Inmar will provide the materials needed to return their medication and instructions for reimbursement.

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.

Patient safety and product quality are critical to Teva. Teva will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.


Company Contact Information

Media:
Kelley Dougherty, Eric Rubin


Product Photos

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Author: FDA

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