Drug recall D-0491-2025

Class II Ongoing reported Jul 2, 2025

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.

Reason for recall

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Lots and codes

Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027

Recall details

Recalling firm
B BRAUN MEDICAL INC, Allentown, PA
Quantity
187,656 containers
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 16, 2025

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