Sterile Water for Inj — Class II drug recall D-0384-2021
Terminated recall by Pfizer Inc., reported 2021-05-26, distributed nationwide. Presence of Particulate Matter: particulate matter identified as an insect in one vial.
| Recall number | D-0384-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2021-05-03 |
| Classified | 2021-05-14 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2023-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 49,525 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-4887, 00409-4887-05, 00409-4887-10, 00409-4887-17, 00409-4887-20, 00409-4887-23, 00409-4887-24, 00409-4887-25, 00409-4887-31, 00409-4887-32, 00409-4887-34, 00409-4887-50, 00409-4887-99 |
| Lot numbers | DN9185 |
Product
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
Reason for recall
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
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-0384-2021. 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.