Recalls / Class II
Class IID-0288-2022
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
- Affected lot / code info
- Lot #: 2130958; Expiration Date 03/31/2022
Why it was recalled
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, N/A, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 1440 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-11-29
- FDA classified
- 2021-12-17
- Posted by FDA
- 2021-12-29
- Terminated
- 2022-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0288-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.