Neut Sodium Bicarbonate 4% — Class II drug recall D-1049-2017
Terminated recall by Hospira a Pfizer Company, reported 2017-08-09, distributed in PR. Lack of Sterility Assurance
| Recall number | D-1049-2017 |
|---|---|
| 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 | 21,436,700 |
| Reason classes | sterility |
| NDC | 00409-6609-02, 00409-6609-25 |
| Lot numbers | 72226EV, 72236EV, 75382EV, 75383EV, 7538EV |
| Expiration dates | 2018-12-01, 2019-03-01 |
Product
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
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-1049-2017. 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.