5% DEXTROSE Injection — Class II drug recall D-0417-2015
Terminated recall by Hospira Inc., reported 2015-03-25, distributed nationwide. Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the pr
| Recall number | D-0417-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-03-05 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-12-09 |
| Distributed | Nationwide (US) |
| Quantity | 94,440 bags |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00304040971000, 30304097100027 |
| NDC | 00409-7100, 00409-7100-02, 00409-7100-04, 00409-7100-66, 00409-7100-67, 00409-7100-68, 00409-7100-69 |
| Lot numbers | 37-042-JT |
| Expiration dates | 2016-01-01 |
Product
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.
Reason for recall
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
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-0417-2015. 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.