FDA Drug recall D-0362-2024
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
- FDA Drug
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42 by Denver Solutions, citing presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0362-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-20 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denver Solutions |
| Distribution | US |
Product
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Reason
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Identifiers
| code_info | Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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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-0362-2024%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.