D-0334-2015 Class II Terminated
FDA drug recall D-0334-2015 was initiated by Hospira Inc. on Dec 22, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port. The recall status is terminated (terminated Jul 2, 2015). Affected quantity: 30840 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 14, 2015
- Initiation Date
- Dec 22, 2014
- Termination Date
- Jul 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30840 bags
Product Description
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
Reason for Recall
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Distribution Pattern
Nationwide
Code Information
Lot #: 42-306-C6
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0334-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026