D-1096-2014 Class II Terminated
FDA drug recall D-1096-2014 was initiated by Hospira Inc. on Feb 11, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. The recall status is terminated (terminated Mar 17, 2015). Affected quantity: 603,768 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 12, 2014
- Initiation Date
- Feb 11, 2014
- Termination Date
- Mar 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 603,768 bags
Product Description
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Reason for Recall
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 34-609-FW; Exp 10/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1096-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026