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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
D-887-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,110 vials
- Official record key
drug-enforcement:D-887-2013
Official wording
Reason: Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Code information: Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter