Drug product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
D-66637-001
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70,450 vials
- Official record key
drug-enforcement:D-66637-001
Official wording
Reason: Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Code information: Lot #: 27-570-DJ, Exp 03/01/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter