Baxter Recalls Two Lots of NaCl IV Solution
Baxter International Inc. is voluntarily recalling two lots of intravenous (IV) solutions, sodium chloride injection, 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 matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.
The two lots were respectively for 0.9% sodium chloride injection, USP, 50 mL Viaflex plastic container and 0.9% sodium chloride injection, USP, 100-mL Mini-Bag Plus Container. 0.9 % sodium chloride injection, USP, 50 mL VIAFLEX Plastic Container is intended for intravenous use as a source of water and electrolytes. 0.9% sodium chloride Injection, USP, 100 mL Mini-Bag Plus Container is indicated as a source of water and electrolytes and may also be used as a diluent for reconstitution of a powdered drug product packaged in a vial with a 20-mm closure.
The lots being recalled were distributed to customers and distributors in the United States between October 7, 2014 and July 14, 2015.
Source: Baxter International and FDA