Baxter Recalls IV Solutions
Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.
FDA reported on April 9, 2015 that Baxter International has voluntarily recalled select lots of intravenous (IV) solutions for possible particulate matter. The IV solutions include Sodium Chloride Injection, USP, indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures; Dextrose Injection, USP, indicated as a source of water and calories; and Lactated Ringer’s Injection, USP, indicated as a source of water and electrolytes, or as an alkalinizing agent. The recalled lots were distributed in the United States and Bermuda between Jan. 14, 2015 and March 5, 2015.
Baxter personnel discovered the particulates while performing routine maintenance and identified the particulates as material from a solution transmission system pump. The company has not yet received any adverse event reports or complaints.
A full list of recalled lots can be found on FDA’s website.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
