Drug product
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA
D-0494-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 bags
- Official record key
drug-enforcement:D-0494-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 2007046.1
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations