D-0495-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2026
- Initiation Date
- April 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,928 bags
Product Description
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 for Recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Distribution Pattern
US Nationwide.
Code Information
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.