FDA Issues Urgent Update on Leachable Nitrosamine Impurities in Infusion Bags

In August, the FDA released an important update regarding mutagenic impurities, specifically N-nitrosodibutylamine (NDBA), which has been detected in drug products packaged in infusion bags. Early evidence suggests that these small molecule nitrosamine impurities may be leaching from sources such as overwraps or label printing inks into drug products.

While the FDA has confirmed that manufacturing and supply can continue, the Centre for Drug Evaluation and Research (CDER) has issued an urgent call for action. All manufacturers of drug products packaged in infusion bags are expected to take immediate steps to evaluate this emerging risk.

The FDA’s update recommends that applicants:

• Conduct a risk assessment of drug products packaged in infusion bags.
• Test three representative batches within label expiry, prioritising those identified as highest risk.
• Submit revised information within 90 days of the recommendation (deadline: 16 November 2025).

Cormica understands how impactful and concerning regulatory updates such as this can be. Our laboratories are equipped with in-house methodologies capable of detecting small molecule nitrosamines, including NDBA, at trace levels down to pg/mL (ppt). With a depth of expertise in both nitrosamine screening and quantification, as well as the associated regulatory requirements, we are ready to support you in evaluating your products and meeting compliance expectations.

To explore this subject in more depth, join our upcoming Impurities Webinar with live Q&A, where our experts will discuss nitrosamine analysis, regulatory challenges, and practical testing approaches. Join the webinar here