FDAFDA · Food and drugs·Recall number D-0491-2025
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Published July 2, 2025 · Recall initiated: June 16, 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: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Distributor
- USA Nationwide
- Lot
- Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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