Drug product
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
D-0094-2017
Product summary
- Event
- Event 73626
- Status
- Terminated
- Classification
- Class I
- Quantity
- 57,408 units
- Official record key
drug-enforcement:D-0094-2017
Official wording
Reason: Non-Sterility: fungal contamination due to leaking containers.
Code information: Lot #: J5J706, Exp. 10/31/2016
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
fungal contamination