Drug product
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
D-0496-2026
Product summary
- Event
- Event 98693
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,124 bags
- Official record key
drug-enforcement:D-0496-2026
Official wording
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Code information: Lot # J5H166, J5H167, Exp Date: 30NOV2026.
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility