Nostrum Laboratories recalls lots of metformin tablets after nitrosamine detection
Company is the latest in a lengthening list of pharma companies recalling the diabetes medicine over unacceptable levels of NDMA
Nostrum Laboratories has become the latest pharmaceutical company to voluntarily recall lots of its version of diabetes medicine, metformin, after they were found to contain excessive levels of nitrosamine impurities.
The Missouri-based company said it is recalling two lots of 750 mg metformin HCl extended release tablets, which were found to contain levels of N-Nitrosodimethylamine (NDMA) above the US Food and Drug Administration’s ADI limit of 96 ng/day.
NDMA, a chemical form of nitrosamine, is classified as a probable human carcinogen and a possible cause of cancer.
Nostrum said it has not received any reports of adverse events related to the recall. It added it is notifying its distributors by letter and is arranging for return of all recalled products.
The case in the latest in a series of metformin recalls due to the presence of nitrosamine by pharmaceutical companies, including Amneal, Lupin and Marksans.
Metformin is used to treat type II diabetes and is designed to lower glucose levels.
Nitrosamines are genotoxic substances which may increase the risk of cancer in people exposed to above acceptable levels over longer periods of time. The issue of contamination in pharmaceutical products first arose in 2018 when the FDA detected impurities in Angiotensin II receptor blockers (ARBs).
Soon after, several ‘sartan’ medicines were also found to include nitrosamine impurities, leading to product recalls and a new set of manufacturing requirements for those medicines.
And most recently, the European Medicine Agency’s Committee on Human Medicinal Products said it was asking marketing authorization holders for medicines containing metformin – an oral drug used to control high blood sugar in patients with type II diabetes -- to test their medicines for nitrosamine before releasing them onto the market.
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
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