D-183-2013 Class II Terminated
FDA drug recall D-183-2013 was initiated by Hospira Inc. on Jan 8, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal. The recall status is terminated (terminated May 15, 2015). Affected quantity: 325,056 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 13, 2013
- Initiation Date
- Jan 8, 2013
- Termination Date
- May 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 325,056 bags
Product Description
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Reason for Recall
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Distribution Pattern
Nationwide
Code Information
Lot Number 02-117-JT Exp. 02/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-183-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026