Mylan Pharmaceuticals is voluntarily recalling three lots of an ulcer medication that has been found to contain trace amounts of a potential carcinogen.
The three batches of 150 mg and 300 mg Nizatidine Capsules USP were distributed by Mylan Pharmaceuticals and distributed nationwide between June 2017 and August 2018 to wholesalers, mail order pharmacies and retail pharmacies.
Mylan said in a release the Nizatidine contained a trace amount of N-nitrosodimethylamine (NDMA) in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Ltd. Mylan is the final manufacturer.
The medication, Nizatidine, is used to treat active duodenal ulcers and active benign gastric ulcers, as well as maintenance therapy for duodenal ulcer. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
NDMA is a known environmental contaminant. It can be found in water and foods, including meats, dairy products and vegetables. It has also been classified as a probable human carcinogen.
Mylan is in the process of merging with Upjohn — a division of Pfizer. When the merger is completed sometime this year, the new company will be known as Viatris, a Latin derivative that represents the new company’s “path to three” core goals.
“Expanding access to medicines, leading by innovating to meet patient needs and being a trusted partner for the health care community worldwide,” Mylan said in a November release.
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