Baxter Initiates Voluntary Recall of Two Lots of Sodium Chloride Solution

Baxter International Inc. has voluntarily initiated a recall in the United States of two lots of 0.9% sodium chloride injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter. The issue was identified upon standard visual inspection prior to patient administration.

0.9% sodium chloride Injection USP in 100 mL MINI-BAG PLUS Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single-dose powdered drug. This recall affects the following lots of 0.9% sodium chloride injection USP in 100 mL MINI-BAG PLUS Container.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization (blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver). There have been no reported adverse events for the affected lots.

Source: Baxter International and US Food and Drug Administration

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