FDA-Drug2025-07-02Class II
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
Hazard
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Sold states
USA Nationwide
Affected count
187,656 containers
Manufactured in
861 Marcon Blvd, Allentown, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2025Don't want to check this manually?
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