Drug product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
D-297-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 245,250 vials
- Official record key
drug-enforcement:D-297-2013
Official wording
Reason: Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Code information: Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter