D-243-2013 Class II Terminated
FDA drug recall D-243-2013 was initiated by Hospira Inc. on Feb 18, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak… The recall status is terminated (terminated Apr 6, 2015). Affected quantity: 624,240 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 10, 2013
- Initiation Date
- Feb 18, 2013
- Termination Date
- Apr 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 624,240 units
Product Description
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
Reason for Recall
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Distribution Pattern
Nationwide
Code Information
Lot #: 22-028-JT Exp 04/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-243-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026