VANCOmycin HCl PF 1 — Class I drug recall D-0281-2024
Ongoing recall by Denver Solutions, LLC DBA Leiters Health, reported 2024-02-07, distributed nationwide. Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug produ
| Recall number | D-0281-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health, Englewood, CO, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-01-29 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 10,152 iv |
| Reason classes | potency, device malfunction |
| NDC | 71449-0028-68 |
| Lot numbers | 2331184, 2331185, 2331189, 2331191, 2331258, 2331317 |
| Model numbers | F3206 |
| Expiration dates | 2024-02-10, 2024-02-13, 2024-02-20, 2024-02-24, 2024-03-03, 2024-03-15 |
Product
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Reason for recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
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-0281-2024. 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.