Apotex recalls diabetes drug after FDA alert

Apotex, a drugmaker based in Toronto, is recalling all lots of its metformin extended-release tablets after the FDA said it found unacceptable levels of a carcinogen in the drug. 

The FDA said May 27 that after months of testing, it discovered metformin extended-release products contain levels higher than the acceptable limit of N-Nitrosodimethylamine, or NDMA, a carcinogen. 

Apotex's metformin products are used to improve blood sugar control in people with Type 2 diabetes. The drugmaker stopped selling it in the U.S. in February 2019, so only a limited amount is left on the market, the company said. 

Apotex hasn't received any adverse event reports related to the drug and said it is recalling all lots "out of an abundance of caution."

The drugmaker said any wholesalers, distributors or retailers with the drug should return it and any consumers with it should quarantine it immediately. 

Read the full news release here

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars