Consumer Alerts Tracker
openFDA Drug

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.

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

Official details

Category
Drug recall
Status
Ongoing
Classification
Class II
Company or vendor
B BRAUN MEDICAL INC
Affected product
US Nationwide.
Risk or reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Remedy or action
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Official ID
D-0495-2026