D-608-2013 Class II Terminated
FDA drug recall D-608-2013 was initiated by Hospira Inc. on Jun 6, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container. The recall status is terminated (terminated May 15, 2015). Affected quantity: 676,872 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 26, 2013
- Initiation Date
- Jun 6, 2013
- Termination Date
- May 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 676,872 containers
Product Description
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
Reason for Recall
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-608-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026