Potassium Phosphates Inj — Class II drug recall D-1046-2017
Terminated recall by Hospira a Pfizer Company, reported 2017-08-09, distributed in PR. Lack of Sterility Assurance
| Recall number | D-1046-2017 |
|---|---|
| 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 | 20,337,650 |
| Reason classes | sterility |
| NDC | 00409-7295-01 |
| Lot numbers | 74119EV, 74120EV, 74121EV, 74307EV, 75215EV, 75326EV, 75327EV |
| Expiration dates | 2019-02-01, 2019-03-01 |
Product
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
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-1046-2017. 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.