Drug product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
D-1547-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67936
- Status
- Terminated
- Classification
- Class I
- Quantity
- 844,300 vials
- Official record key
drug-enforcement:D-1547-2014
Official wording
Reason: Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Code information: Lot #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter