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.
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The nizatidine recall comes months after positive NDMA testing triggered waves of global recalls and distribution halts for popular heartburn med Zantac (ranitidine).