D-932-2013 Class II Terminated
FDA drug recall D-932-2013 was initiated by Hospira Inc. on Aug 14, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. The recall status is terminated (terminated Sep 18, 2014). Affected quantity: 283,150 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 18, 2013
- Initiation Date
- Aug 14, 2013
- Termination Date
- Sep 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 283,150 vials
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
Reason for Recall
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Distribution Pattern
Nationwide
Code Information
Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number 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-932-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026