Five drug manufacturers have recalled products containing metformin

The U.S. Food and Drug Administration announced in late May that some products containing metformin were found to have been contaminated by N-Nitrosodimethylamine (NDMA), a probable carcinogen. Five drug manufacturers have since recalled products containing metformin:

Apotex Corp. announced they were voluntarily recalling their 500mg Metformin Hydrochloride Extended-Release Tablets, USP on May 27. This product came in bottles of 100 tablets and its NDC number was 60505-0260-1. These tablets were distributed nationwide in the United States to warehousing chains.

Amneal Pharmaceuticals LLC announced they were voluntarily recalling all lots of their 500mg and 750mg Metformin Hydrochloride Extended Release Tablets, USP, on May 29. These products came in bottles of 90, 100, 500 and 1,000 tablets as well as bulk boxes. These tablets were distributed nationwide in the United States to repackagers, retailers, distributors and wholesalers.

Marksans Pharma Limited announced they were voluntarily recalling their 500mg Metformin Hydrochloride Extended-Release Tablets, USP, on June 2. This product came in bottles of 100 tablets and its NDC number was 49483-621-01. These bioconvex tablets are white to off white, shaped like capsules, debossed with “101” on one side and plain on the other side.

Teva Pharmaceuticals USA, Inc. announced they were voluntarily recalling 14 lots of their 500mg and 750mg Metformin Hydrochloride Extended-Release Tablets, USP on June 2. These products came in bottles of 100 and 1,000 tablets and were distributed nationwide to Teva’s direct customers.

Lupin Pharmaceuticals, Inc. announced they were voluntarily recalling one lot of their 500mg Metformin Hydrochloride Extended-Release Tablets USP on June 11. This product came in bottles of 60 tablets and its NDC number was 68180-336-07. This product was distributed nationwide in the United States to mail order pharmacies, distributors and wholesalers.

The U.S. Environmental Protection Agency considers NDMA to be a probable carcinogen. Scientists give NDMA to rats to give the rats cancer which the scientists can then study.

HSA found NDMA contamination in three medications containing metformin and announced the finding in December 2019. Testing lab Valisure then tested 38 batches of the drug for NDMA. The company found that 16 of the batches contained more NDMA than the 96 nanogram daily acceptable intake limit. The company also found that many of the batches contained over 10 times the intake limit.

Multiple medications have been found to be contaminated by NDMA in recent times, including Zantac and valsartan.

Tags

About the author

Nadrich & Cohen, LLP

Nadrich & Cohen, LLP is a California personal injury law firm with offices in Los Angeles, San Francisco, Modesto, Fresno, Tracy and Palm Desert. The firm has been representing victims of dangerous drugs since 1990 and has recovered over $350,000,000 on behalf of clients in that time.

Add Comment

Click here to post a comment

Your email address will not be published. Required fields are marked *