0 — Class II drug recall D-0490-2015
Terminated recall by Hospira Inc., reported 2015-04-29, distributed nationwide. Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
| Recall number | D-0490-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-04-07 |
| Classified | 2015-04-17 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2016-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 128,050 add |
| Reason classes | sterility, packaging |
| NDC | 00409-7101, 00409-7101-02, 00409-7101-04, 00409-7101-66, 00409-7101-67, 00409-7101-68, 00409-7101-69, 00409-7132, 00409-7132-02, 00409-7132-04, 00409-7132-66, 00409-7132-67, 00409-7132-68, 00409-7132-69 |
| Lot numbers | 08/16, 44-110-JT |
Product
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
Reason for recall
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
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-0490-2015. 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.