FDAJune 16, 2025drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
What to do
FDA enforcement status: Ongoing
Brands named
b braun medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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