D-614-2013 Class II Terminated
FDA drug recall D-614-2013 was initiated by Hospira Inc. on May 4, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. The recall status is terminated (terminated Jul 17, 2015). Affected quantity: 267,288 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 3, 2013
- Initiation Date
- May 4, 2012
- Termination Date
- Jul 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 267,288 units
Product Description
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
Reason for Recall
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Distribution Pattern
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Code Information
Lot #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-614-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026