Mylan recalls batches of Nizatidine capsules after nitrosamine detected in API

9 Jan 2020

The US arm of generic and specialty pharma company Mylan Pharmaceuticals has recalled three lots of its heartburn drug Nizatidine in capsule form amid fears of possible nitrosamine contamination.

The voluntary nationwide recall comes after trace amounts of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) were detected in the active pharmaceutical ingredient (API) supplied by India-based Solara Active Pharma Sciences Ltd.

Mylan recalls batches of Nizatidine capsules after nitrosamine detected in API

Mylan said it had recalled three lots of Nizatidine capsules, including the 150mg and 300mg strengths, which were distributed to wholesalers, mail order pharmacies, wholesale and retail pharmacies and a distributor between June 2017 and August 2018.

The company has so far not received any reports of adverse events related to these batches, it added.

The action marks the latest in a string of recalls prompted by the potential risk of nitrosamine impurities in medications that have rocked the API manufacturing sector over the last two years.
The US Food and Drug Administration first said it had detected NDMA in Angiotensin II receptor blockers used to treat blood pressure and heart conditions and heartburn drug, ranitidine, sold under the brand name Zantac among others, back in July 2018.

The drug regulator has asked manufacturers of nizatidine and ranitidine to test their products for NDMA and send samples in. It is also conducting ongoing investigations into the presence of nitrosamine in other drug products.

Meanwhile, the European Medicines Agency has asked manufacturers to complete a risk assessment of products potentially affected by 26 March this year.

NDMA, a chemical form of nitrosamine and generally found in water and foods, including processed meats dairy products and vegetables, is classified as a probable human carcinogen that could cause cancer.

Nizatidine is a histamine H2 receptor antagonist used to treat active duodenal ulcers and benign gastric ulcers as well as gastroesophageal reflux disease. It was first approved for medical use in 1987.

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