Moxifloxacin PF — Class II drug recall D-0361-2024
Ongoing recall by Denver Solutions, LLC DBA Leiters Health, reported 2024-03-06, distributed nationwide. Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
| Recall number | D-0361-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health, Englewood, CO, United States |
| Recall initiated | 2024-02-20 |
| Classified | 2024-02-29 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 40,090 vials |
| Reason classes | foreign material, specification failure |
| NDC | 71449-0096-42 |
| Lot numbers | 2331147, 2331180, 2331256, 2331279, 2331283, 2331345, 2331422, 2331563 |
| Expiration dates | 2024-03-06, 2024-03-21, 2024-04-02, 2024-04-03, 2024-04-07, 2024-04-20, 2024-04-27, 2024-05-29 |
Product
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Reason for recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0361-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.