Sterile Water for Injection USP recalled over sterility concerns
- Recall date
- April 2, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- B BRAUN MEDICAL INC recalls Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 180…
- Recall number
- D-0495-2026
- FDA classification
- Class II
- Brand / firm
- B BRAUN MEDICAL INC
- Sold / distributed
- US Nationwide.
Why it was recalled
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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