FDAFDA · Food and drugs·Recall number D-0495-2026
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.
Published April 29, 2026 · Recall initiated: April 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- STERILE WATER
- Manufacturer
- B BRAUN MEDICAL INC
- Distributor
- US Nationwide.
- Lot
- Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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