D-223-2013 Class II Terminated
FDA drug recall D-223-2013 was initiated by Hospira Inc. on Feb 25, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection. The recall status is terminated (terminated Oct 8, 2014). Affected quantity: 68,020 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 3, 2013
- Initiation Date
- Feb 25, 2013
- Termination Date
- Oct 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,020 vials
Product Description
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
Reason for Recall
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Distribution Pattern
Nationwide.
Code Information
a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number 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-223-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026