News|Articles|July 20, 2015

Insect in IV Solution Prompts Baxter Recall

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

Baxter International Inc. announced on July 17 that it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter.

The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint, the company reports. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.

This recall affects two lots of 0.9% sodium chloride injection, USP, 50 mL VIAFLEX Plastic Container, a product intended for intravenous use as a source of water and electrolytes. The lots being recalled were distributed to customers and distributors in the United States between Oct. 7, 2014 and July 14, 2015.

Source: Baxter International

 

 


Related to this article

Intravenous therapy; drip chamber in focus against a colorful background | Image Credit: ©Anna Jurkovska -stock.adobe.com
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.