Drug product
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
D-1672-2012
Product summary
- Firm
- Hospira Inc.
- Event
- Event 62999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,420 vials
- Official record key
drug-enforcement:D-1672-2012
Official wording
Reason: Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Code information: 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter