0 — Class II drug recall D-243-2013
Terminated recall by Hospira Inc., reported 2013-04-10, distributed nationwide. Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released
| Recall number | D-243-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-02-18 |
| Classified | 2013-04-04 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2015-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 624,240 units |
| Reason classes | sterility, packaging |
| NDC | 00409-7984-36 |
| Lot numbers | 04/14, 22-028-JT |
Product
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
Reason for recall
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
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-243-2013. 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.