FDAFDA · Food and drugs·Recall number D-0652-2025
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Published September 24, 2025 · Recall initiated: August 26, 2025
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 fluid leakage from the port due to port misalignment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- STERILE WATER
- Manufacturer
- B BRAUN MEDICAL INC
- Distributor
- U.S. Nationwide
- Lot
- Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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