D-176-2013 Class II Terminated
FDA drug recall D-176-2013 was initiated by Hospira Inc. on Feb 12, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container. The recall status is terminated (terminated Apr 24, 2015). Affected quantity: 56,854 Units.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 6, 2013
- Initiation Date
- Feb 12, 2013
- Termination Date
- Apr 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,854 Units
Product Description
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Reason for Recall
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Distribution Pattern
Nationwide
Code Information
Lot 13-121-JT* * the lot number may be followed by 01
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-176-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026