D-1425-2014 Class II Terminated
FDA drug recall D-1425-2014 was initiated by Hospira Inc. on Jun 6, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. The recall status is terminated (terminated Apr 3, 2015). Affected quantity: 142,152 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 16, 2014
- Initiation Date
- Jun 6, 2014
- Termination Date
- Apr 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142,152 bags
Product Description
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
Reason for Recall
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Distribution Pattern
Nationwide
Code Information
Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1425-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026