Drug product
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
D-0288-2022
Product summary
- Event
- Event 89136
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1440 vials
- Official record key
drug-enforcement:D-0288-2022
Official wording
Reason: Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Code information: Lot #: 2130958; Expiration Date 03/31/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up