Lidocaine HCL 1% — Class II drug recall D-0363-2024
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-0363-2024 |
|---|---|
| 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 | 40,890 vials |
| Reason classes | foreign material, specification failure |
| NDC | 71449-0090-42 |
| Lot numbers | 2331104, 2331137, 2331196, 2331264, 2331282, 2331464, 2331481, 2331500 |
| Expiration dates | 2024-03-03, 2024-03-09, 2024-03-11, 2024-04-06, 2024-04-18, 2024-05-08, 2024-05-16, 2024-05-20 |
Product
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
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-0363-2024. 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.