FDA Drug recall D-0490-2015
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101…
- FDA Drug
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101… by Hospira, citing lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0490-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-07 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
Reason
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Identifiers
| ndc | 0409-7101-68 |
|---|---|
| ndc | 0409-7101-66 |
| ndc | 0409-7101-69 |
| ndc | 0409-7101-67 |
| ndc | 0409-7101-04 |
| ndc | 0409-7101-02 |
| ndc | 0409-7132-68 |
| ndc | 0409-7132-66 |
| ndc | 0409-7132-69 |
| ndc | 0409-7132-67 |
| ndc | 0409-7132-04 |
| ndc | 0409-7132-02 |
| code_info | Lot# 44-110-JT; Exp 08/16 |
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-0490-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.