8 — Class II drug recall D-1047-2017
Terminated recall by Hospira a Pfizer Company, reported 2017-08-09, distributed in PR. Lack of Sterility Assurance
| Recall number | D-1047-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira a Pfizer Company, Rocky Mount, NC, United States |
| Recall initiated | 2017-06-15 |
| Classified | 2017-08-01 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2020-07-20 |
| Distributed | PR |
| Countries outside the US | BB, CA, KW, PH, SG |
| Quantity | 91,483,150 |
| Reason classes | sterility |
| NDC | 00409-6625-02 |
| Lot numbers | 72109EV, 72110EV, 72112EV, 72113EV, 72114EV, 73068EV, 73071EV, 73072EV, 73224EV, 73225EV, 73230EV, 73231EV, 73232EV, 73233EV, 73234EV, 73235EV, 73236EV, 73298EV, 74058EV, 74104EV, 74105EV, 74106EV, 74107EV, 74197EV, 74198EV, 74199EV, 74200EV, 74201EV, 75171EV, 75172EV, 75173EV, 75174EV, 75175EV, 75176EV, 75177EV, 75178EV, 75293, 75418EV, 75419EV |
| Expiration dates | 2018-12-01, 2019-01-01, 2019-02-01, 2019-03-01 |
Product
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
Reason for recall
Lack of Sterility Assurance
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-1047-2017. 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.