Mylan recalls batches of Nizatidine capsules after nitrosamine detected in API
![](/46/pdcnewsitem/08/15/26/Mylan-recalls-batches-Nizatidine-capsules.jpeg)
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 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.
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance