8 — Class I drug recall D-1073-2019
Terminated recall by Pfizer Inc., reported 2019-04-10, distributed in PR. Presence of Particulate Matter; glass particulates
| Recall number | D-1073-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-03-29 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2021-01-27 |
| Distributed | PR |
| Quantity | 283,400 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-6625-02 |
| Lot numbers | 79-238-EV, 79-240-EV, 80-088-EV |
| Expiration dates | 2019-07-01, 2019-08-01 |
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
Reason for recall
Presence of Particulate Matter; glass particulates
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-1073-2019. 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.