Drug product
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
D-1257-2020
Product summary
- Event
- Event 85507
- Status
- Terminated
- Classification
- Class I
- Quantity
- 22,488 Duplex containers
- Official record key
drug-enforcement:D-1257-2020
Official wording
Reason: Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Code information: Lot #: H8J812, Exp. Date 31 JUL 2020
Distribution pattern: Product was distributed nationwide within the United States.
Derived failure modes
-
Potency or specification failure
Out-of-Specification