D-0491-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 2, 2025
- Initiation Date
- June 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187,656 containers
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.
Reason for Recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Distribution Pattern
USA Nationwide
Code Information
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027