D-0490-2015 Class II Terminated
FDA drug recall D-0490-2015 was initiated by Hospira Inc. on Apr 7, 2015 and is designated Class II. Reason for recall: Lack of Sterility Assurance: The product has the potential to leak at the administrative port. The recall status is terminated (terminated Nov 4, 2016). Affected quantity: 128,050 ADD-Vantage flexible containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 29, 2015
- Initiation Date
- Apr 7, 2015
- Termination Date
- Nov 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128,050 ADD-Vantage flexible containers
Product Description
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 for Recall
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Distribution Pattern
Nationwide
Code Information
Lot# 44-110-JT; Exp 08/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0490-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026