Mylan snared in carcinogen scare with voluntary nizatidine recall
An FDA recall affects three lots of nizatidine sold between June 2017 and August 2018. (Mylan)
Following a global withdrawal of both generic statins and heartburn med Zantac, a spotlight has been trained on manufacturing that resulted in carcinogen-tainted drugs. Now, months after the Zantac scare, Mylan is the latest drugmaker forced to backtrack distribution of a popular generic.
Mylan will recall three U.S. lots of nizatidine, USP, capsules after trace amounts of a probable carcinogen, N-Nitrosodimethylamine (NDMA), were found in the active pharmaceutical ingredient (API) in tested batches, the company said. The drug's API was produced by India-based drugmaker Solara Active Pharma Sciences.
Mylan's tainted batches of generic nizatidine, approved as a short-term treatment for duodenal ulcers, were distributed through June 2017 and August 2018, and no adverse events have been reported so far, the drugmaker said.
The nizatidine recall comes months after positive NDMA testing triggered waves of global recalls and distribution halts for popular heartburn med Zantac (ranitidine).