FDA Drug recall D-608-2013
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC…
- FDA Drug
- Class II
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC… by Hospira, citing lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-608-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-06 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Identifiers
| code_info | Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-608-2013%22
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