D-0417-2015 Class II Terminated
FDA drug recall D-0417-2015 was initiated by Hospira Inc. on Mar 5, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container. The recall status is terminated (terminated Dec 9, 2016). Affected quantity: 94,440 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 25, 2015
- Initiation Date
- Mar 5, 2015
- Termination Date
- Dec 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,440 bags
Product Description
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 for Recall
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Distribution Pattern
Nationwide
Code Information
Lot: 37-042-JT, Exp 1JAN2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0417-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026