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.

Related categories

Related tags

Market News

Related news

Can the industry really claim it's 'business as usual'?

Can the industry really claim it's 'business as usual'?

19 May 2020

ChargePoint Technology's Chief Commercial Officer says "yes" it can.

Read more 
HKBU scientists develop technique to eliminate drug side effects

HKBU scientists develop technique to eliminate drug side effects

19 May 2020

The novel method paves the way towards the mass production of affordable therapeutic drugs that are made with recyclable materials.

Read more 
Samsung Biologics expands business continuity excellence with additional ISO 22301 certification

Samsung Biologics expands business continuity excellence with additional ISO 22301 certification

19 May 2020

The certification is expected to instill greater 'supply' trust with clients, particularly during the current pandemic.

Read more 
Vibalogics agrees to additional manufacturing for lead COVID-19 vaccine candidate of J&J unit

Vibalogics agrees to additional manufacturing for lead COVID-19 vaccine candidate of J&J unit

18 May 2020

CDMO is contracted to produce multiple clinical batches from German facility

Read more 
Pharmapack expert recommends holistic approach to sustainability

Pharmapack expert recommends holistic approach to sustainability

18 May 2020

Although the industry might be 30% along its sustainability journey, greater interoperability is needed from materials to devices.

Read more 
KND Labs earns Active Pharmaceutical Ingredients certification for CBD ingredients

KND Labs earns Active Pharmaceutical Ingredients certification for CBD ingredients

12 May 2020

Company's manufacturing methods and processes reviewed by an independent third-party auditor to ensure the products have the highest-quality ingredients possible.

Read more 
Characterizing virus and virus-like particles

Characterizing virus and virus-like particles

12 May 2020

New application study describes the separation and characterisation of adeno associated virus serotypes by AF4.

Read more 
Recipharm increases API and raw material stocks to ensure supply amid higher antibiotics demand

Recipharm increases API and raw material stocks to ensure supply amid higher antibiotics demand

12 May 2020

CDMO says it has made "notable changes" to its supply chain processes to ensure continuing supply of medicines during COVID-19 pandemic

Read more 
AI technology company launches with Novartis and Sarepta deals

AI technology company launches with Novartis and Sarepta deals

11 May 2020

Collaborations focus on gene therapies for serious eye and muscle diseases using Dyno’s CapsidMap artificial intelligence platform to design AAV vectors.

Read more 
Demand for immunity products to be sustained long-term says SIRIO

Demand for immunity products to be sustained long-term says SIRIO

11 May 2020

Movement towards healthy lifestyles and preventative supplements the lasting behavioural change post COVID-19.

Read more