---
type: "WebPage"
title: "Nitrosamines in IV bags: what does the FDA say and how to protect yourself?"
description: "NDBA Nitrosamine analysis and the FDA alert: a major issue for the Pharmaceutical Industry What is N-nitroso-dibutylamine (NDBA)? Nitrosamines are chemical compounds known for their carcinogenic potential.N-Nitroso-dibutylamine (NDBA) is a compound in the nitrosamine family and can be formed during..."
resource: "https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/nitrosamines-fda/"
tags: ["EN", "Anaïs DECAUX"]
timestamp: "2025-12-31T08:32:26Z"
published: "2025-08-29T06:47:52Z"
language: "en"
author: "Laure Durieux"
---

# Nitrosamines in IV bags: what does the FDA say and how to protect yourself?

## NDBA Nitrosamine analysis and the FDA alert: a major issue for the Pharmaceutical Industry

### What is N-nitroso-dibutylamine (NDBA)?

Nitrosamines are chemical compounds known for their carcinogenic potential.

**N-Nitroso-dibutylamine (NDBA)** is a compound in the nitrosamine family and can be formed during the manufacturing or storage of certain pharmaceutical products.

The presence of NDBA in drugs packaged in **infusion bags** raises significant regulatory compliance concerns for pharmaceutical manufacturers.

### The recent FDA alert: key issues and dates

On **August 18, 2025**, the FDA confirmed the detection of NDBA in certain infusion bags. This announcement triggered an **obligation for manufacturers to reevaluate their processes and materials to avoid any risk of contamination**. The challenge is twofold:

- Patient safety: preventing exposure to potentially harmful substances
- Regulatory compliance: documenting and communicating to authorities the measures taken to limit nitrosamines

### Obligations for manufacturers

In response to this alert, **manufacturers must implement several measures**:

- **Evaluation of packaging materials**: films, outer bags, inks, and other components must be analyzed to detect any risk of nitrosamine formation.
- **Ultra-sensitive analysis**: nitrosamines are active at ultra-trace levels (ppb), requiring sophisticated analytical techniques.
- **Documentation and traceability**: all actions and results must be recorded and communicated to the relevant authorities.

These steps are essential to comply with FDA requirements.

  [Learn more about our nitrosamine analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines.md)
## Ultra-sensitive nitrosamine analysis and support from an expert nitrosamine laboratory

As an analysis and expertise laboratory, FILAB offers:

- Determination of ultra-trace nitrosamines using our [state-of-the-art equipment](https://filab.fr/en/our-technical-resources.md)
- Characterization of materials and inks to identify potential sources of contamination
- Comprehensive scientific support to guide you through your regulatory procedures and audits

**Our expertise allows you to respond quickly and efficiently to FDA requirements.**

 [FDA requirements](https://www.fda.gov/media/188238/download)