FDA Drug recall D-0288-2022
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewoo…
- FDA Drug
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewoo… by Denver Solutions, citing labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0288-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-29 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denver Solutions |
| Distribution | US |
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
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Identifiers
| code_info | Lot #: 2130958; Expiration Date 03/31/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-04-30 · Denver Solutions - Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
FDA Drug · Class II · 2025-04-30 · Denver Solutions - Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
FDA Drug · Class II · 2025-04-30 · Denver Solutions - Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71…
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0288-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.