Particulate Matter Prompts Baxter's Recall of IV Solutions - - BioPharm International

ADVERTISEMENT

Particulate Matter Prompts Baxter's Recall of IV Solutions


Baxter International Inc. announced a voluntary recall of four lots of intravenous solutions to the hospital/user level due to the presence of particulate matter identified as cellulosic fibers and/or plastics. Baxter reports it received four complaints over a period of six months from customers whose visual inspection identified the appearance of visible particulate matter prior to administration to a patient.

The company says an investigation is underway to determine root cause.

If infused, adverse health consequences of particulate matter could vary depending on the amount of particulate matter injected into the patient, the size of the particles, and the patient’s underlying medical condition. There have been no reported adverse events associated with this issue to date, Baxter reports.

The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014. Baxter has notified customers, who are being directed not to use products from the recalled lots.

This recall is being conducted with the knowledge of the FDA.

Source: FDA and Baxter

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
USP Center in Ghana Receives International Lab Accreditation
August 15, 2014
USP Awards Analytical Research
August 15, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
Author Guidelines

Click here