D-184-2013 Class II Terminated
FDA drug recall D-184-2013 was initiated by Hospira Inc. on Oct 22, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag. The recall status is terminated (terminated Mar 31, 2015). Affected quantity: 11,412 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 13, 2013
- Initiation Date
- Oct 22, 2012
- Termination Date
- Mar 31, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,412 bags
Product Description
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Reason for Recall
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Distribution Pattern
Nationwide
Code Information
Lot # 10-199-JT Exp. 10/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-184-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026