B. Braun recalls three lots of 0.9% Sodium Chloride injection due to zinc oxide particles
B. Braun Medical Inc announced a voluntary recall of three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, packaged in a 150 mL PAB® container.
The recall was triggered after testing identified zinc oxide particulate matter in the product, which could pose serious health risks if infused.
The company warned that the particles could cause pulmonary emboli, vascular occlusions, phlebitis, immune activation, organ dysfunction, or hemolysis, though no injuries have been reported to date.
The recall is being issued to hospitals, healthcare facilities, and end users, and B. Braun is working with the FDA to remove the affected lots from the supply chain.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter”
read at fda medwatch ↗
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