Baxter Recalls IV Solution for Container and Particulate Issues
PTSM: Pharmaceutical Technology Sourcing and Management
Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.
Baxter International Inc. announced on July 30, 2015 a voluntary recalling one lot of intravenous (IV) solution-0.9 % Sodium Chloride Injection, USP-to the hospital/user level due to the potential for leaking containers, particulate matter, and missing port protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.
The lot number is C964601 with an expiration date of April 30, 2016.
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
The lot being recalled was distributed to customers and distributors nationwide between January 22, 2015 and February 12, 2015. Customers were notified via letter that they should not use product from the recalled lot.
On July 17, 2015, Baxter recalled two lots of intravenous (IV) solutions due to the potential presence of particulate matter determined to be an insect.
Source: FDA
