0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packa...
FDA Recall #D-0491-2025 — Class II — June 16, 2025
Product Description
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.
Recalling Firm
B BRAUN MEDICAL INC — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
187,656 containers
Distribution
USA Nationwide
Code Information
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated