IV Recalled Due to Potential Presence of Insects
Baxter International Inc., based out of Deerfield, Illinois, is recalling two lots of its IV solutions due the potential presence of particulate matter, according to the U. S. Food and Drug Administration (FDA).
About the Recalled IV Lots
The particulate matter was identified to be an insect due to the results of a customer complaint and was identified prior to patient administration. Due to the early identification of the particulate matter, no adverse effects have been reported to Baxter International.
Baxter International has voluntarily recalled two lots of its intravenous (IV) solutions. The two products are as follows:
- 0.9 % Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container. Lot number: C980227. Product code: 2B1322Q. Expiration Date: 11/30/2016. NDC: 0338-0049-02.
- 70% Dextrose Injection (2000 mL) USP. Lot number: C985150. Product Code: 2B0296H. Expiration Date: 7/31/2016. NDC: 0338-0719-06.
The Sodium Chloride Injection in the plastic container is used as a source for water and electrolytes and may also be used as a priming method in hemodialysis procedures.
The Dextrose Injection is used as a source for calories and water for hydration.
Potential Side Effects of Foreign Particulate Matter
Should someone inject an IV that contains foreign particulate matter, they may experience blockage in the blood vessels which may lead to a stroke, damages to the kidneys or liver, and heart attack. Allergic reactions may occur with the possibility of local inflammation in the tissues and organs.
The recalled lots were distributed to customers in various parts of the United States from June 2015 through December 2015. Baxter International is recommending that all customers immediately stop use of the recalled products.
The recalled products can be returned by contacting Baxter International directly for replacement. This recall does not affect the current supply of the product which remains available for current customers.