Baxter, FDA and CDC Seek to Identify Cause of Multi-Dose Heparin Reactions
This article was originally published in The Gold Sheet
Dangerous reactions led FDA, CDC to seek cause in plant where Baxter makes heparin
You may also be interested in...
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.