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Mylan Recalls Certain Lots Of Nizatidine Capsules

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Mylan Pharmaceuticals, the U.S.-based business of Mylan N.V., recalled certain lots of ulcer medication Nizatidine in the form of capsules for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA).

Trace amounts of the impurity was found in the Active Pharmaceutical Ingredient (API) manufactured by India-based Solara Active Pharma Sciences Ltd.

The generic and specialty pharma company is recalling three lots of Nizatidine Capsules, USP, of 150mg and 300mg strengths of 30 and 60 count bottles with expiration dates of January 2020 and May 2020.

The recalled products were distributed across the U.S. to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.

Mylan has not received any reports of adverse events directly related to the recalled lots.

NDMA, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including meats, dairy products, and vegetables.

Nizatidine is a histamine H2 receptor antagonist that inhibits stomach acid production, and is commonly used in the treatment of active duodenal ulcers and active benign gastric ulcers as well as gastroesophageal reflux disease (GERD). It was patented in 1980 and approved for medical use in 1987.

The company urged consumers to stop using the products and return them immediately.

The U.S. Food and Drug Administration had issued a report in November that Nizatidine exceeded acceptable concentrations of NDMA for human ingestion.

Heartburn medication Ranitidine was also subject to recalls. Several drug companies in the U.S. have issued recalls for Ranitidine, sold under the trade name Zantac among others, on confirmation of NDMA contamination above levels set by the FDA.

The FDA recommended recently that patients taking Ranitidine and Nizatidine to consider alternative drugs such as famotidine, cimetidine, esomeprazole, lansoprazole, and omeprazole, all of which the FDA found did not contain NDMA impurities.

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