D-813-2013 Class II Terminated
FDA drug recall D-813-2013 was initiated by Hospira Inc. on Jun 27, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial. The recall status is terminated (terminated Jun 4, 2015). Affected quantity: 268,700 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 31, 2013
- Initiation Date
- Jun 27, 2013
- Termination Date
- Jun 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 268,700 vials
Product Description
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
Reason for Recall
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Distribution Pattern
Nationwide and Guam
Code Information
Lot #: 15-058-DK*, Exp 1MAR2014; note the * 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-813-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026