0 — Class II drug recall D-608-2013
Terminated recall by Hospira Inc., reported 2013-06-26, distributed nationwide. Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrati
| Recall number | D-608-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-06-06 |
| Classified | 2013-06-20 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2015-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 676,872 containers |
| Reason classes | sterility, packaging |
| NDC | 00409-7983-02 |
| Expiration dates | 2014-04-01 |
Product
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
Reason for recall
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near 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-608-2013. 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.