FDA Drug recall D-0417-2015
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026
- FDA Drug
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026 by Hospira, citing lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0417-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-05 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
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, Hospira, Inc., Lake Forest, IL 60045.
Reason
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Identifiers
| ndc | 0409-7100-68 |
|---|---|
| ndc | 0409-7100-66 |
| ndc | 0409-7100-69 |
| ndc | 0409-7100-67 |
| ndc | 0409-7100-04 |
| ndc | 0409-7100-02 |
| ndc | 0030404097 |
| ndc | 3030409710 |
| code_info | Lot: 37-042-JT, Exp 1JAN2016 |
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-0417-2015%22
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