Class II
Drug Recall: 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
B BRAUN MEDICAL INC · June 16, 2025
Reason for Recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Distribution
USA Nationwide
States Affected
NATIONWIDE
Quantity Affected
187,656 containers
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0491-2025
Status: ongoing
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