FDAHealthApril 2, 2026
B BRAUN MEDICAL INC — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 2, 2026
US Nationwide.
What's affected?
- Product
- 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.
- Brand
- STERILE WATER
- Lot code
- J5H165
Additional details
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 24,928 bags.
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