Drug recall
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged…
FDA recall event 70642 · Class II · Hospira Inc.
Key facts
| Event ID | 70642 |
|---|---|
| Recall numbers | D-0417-2015 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container. |
| Initiation date | Mar 5, 2015 |
| Report date | Mar 25, 2015 |
| Termination date | Dec 9, 2016 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3004591926 |
At a glance
- 1–9 Products in this recall
- 10–99 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: