Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Code information: Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.

Distribution pattern: US Nationwide.