D-0288-2022 Class II Terminated
FDA drug recall D-0288-2022 was initiated by Denver Solutions, LLC DBA Leiters Health on November 29, 2021 and is designated Class II. Reason for recall: Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL The recall status is terminated (terminated July 12, 2022). Affected quantity: 1440 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- December 29, 2021
- Initiation Date
- November 29, 2021
- Termination Date
- July 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1440 vials
Product Description
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
Reason for Recall
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 2130958; Expiration Date 03/31/2022