0 — Class II drug recall D-613-2013
Terminated recall by Hospira Inc., reported 2013-07-03, distributed nationwide. Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bag
| Recall number | D-613-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-05-04 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2015-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | SA |
| Quantity | 136,584 units |
| 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 | 9/12, 93-153-JT |
Product
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
Reason for recall
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
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-613-2013. 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.