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FDARecalled Jul 2, 2025 · #D-0491-2025

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.

Hazard

Class II — temporary health risk

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Description

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. Classification: Class II Distribution: USA Nationwide

Product details

Product
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.
Type
Drugs
Manufacturer
B BRAUN MEDICAL INC
Model numbers
J4L260
UPCs