Why it was recalled
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0491-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 16, 2025
- FDA report date
- Jul 2, 2025
- Quantity
- 187,656 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B BRAUN MEDICAL INC
Original FDA data
Every field from FDA enforcement report D-0491-2025, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97059
- Address
- 861 Marcon Blvd
- Code information
- Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
- Postal code
- 18109-9577
- Report date
- Jul 2, 2025
- Product type
- Drugs
- Recall number
- D-0491-2025
- Classification
- Class II
- Recalling firm
- B BRAUN MEDICAL INC
- Product quantity
- 187,656 containers
- Reason for recall
- Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 16, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2025