Phenylephrine HCl 0 — Class II drug recall D-0442-2023
Terminated recall by Denver Solutions, LLC DBA Leiters Health, reported 2023-03-15, distributed nationwide. CGMP DEVIATIONS
| Recall number | D-0442-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health, Englewood, CO, United States |
| Recall initiated | 2023-02-21 |
| Classified | 2023-03-07 |
| Reported by FDA | 2023-03-15 |
| Terminated | 2024-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 13,445 units |
| Reason classes | cgmp |
| NDC | 71449-0001-11 |
| Lot numbers | 2230960, 2231080 |
| Expiration dates | 2023-03-12, 2023-04-09 |
Product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Reason for recall
CGMP DEVIATIONS
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-0442-2023. 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.