After a carcinogen scare late last year, the FDA recently opted to yank the heartburn drug Zantac and its generics off U.S. shelves. Now, Amneal Pharmaceutical will pull several lots of one of its heartburn meds off the market on fears the same probable carcinogen may have tainted its supply.
Amneal has voluntarily recalled three lots of Nizatidine Oral Solution on fears they contain levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above the FDA's accepted limit.
The drugmaker has not received any adverse effect reports from consumers, Amneal said in a release. The lots were distributed to U.S. pharmacies and retailers by Gemini Solutions, an Amneal subsidiary, through a wholesaler, Amneal said.
Consumer products made with nizatidine, a popular antacid formulation, have come under fire after a nationwide recall of branded and generic Zantac last year on similar NDMA contamination fears.
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In January, Mylan recalled three U.S. lots of nizatidine capsules after trace amounts of 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 had been reported as of January, the drugmaker said.