Drug recall
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc…
FDA recall event 65400 · Class II · Hospira Inc.
Key facts
| Event ID | 65400 |
|---|---|
| Recall numbers | D-608-2013 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jun 6, 2013 |
| Report date | Jun 26, 2013 |
| Termination date | May 15, 2015 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3005579246 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: