4 — Class I drug recall D-0100-2024
Terminated recall by Pfizer Inc., reported 2023-11-15, distributed nationwide. Presence of Particulate Matter: identified as glass.
| Recall number | D-0100-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Terminated | 2025-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 24,900 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-5534-24 |
| Lot numbers | GJ5007 |
| Expiration dates | 2024-08-01 |
Product
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
Reason for recall
Presence of Particulate Matter: identified as glass.
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-0100-2024. 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.