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

FDA recall notice · announced December 29, 2021 · Denver Solutions, Llc Dba Leiters Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 2130958; Expiration Date 03/31/2022
Quantity: 1440 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.