Vancomycin Hydrochloride for Injection — Class I drug recall D-0184-2023
Terminated recall by Pfizer Inc., reported 2023-02-01, distributed nationwide. Presence of Particulate Matter: Glass particulate matter detected in injectable.
| Recall number | D-0184-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-01-25 |
| Reported by FDA | 2023-02-01 |
| Terminated | 2024-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 89,700 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-3515, 00409-3515-01, 00409-3515-11, 00409-4332, 00409-4332-01, 00409-4332-11, 00409-6531, 00409-6531-02, 00409-6531-12, 00409-6533, 00409-6533-01, 00409-6533-11, 00409-6533-21 |
| Lot numbers | 33045BA |
| Expiration dates | 2023-09-01 |
Product
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Reason for recall
Presence of Particulate Matter: Glass particulate matter detected in injectable.
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-0184-2023. 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.