Drug product
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
D-1540-2022
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 90785
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,390 vials
- Official record key
drug-enforcement:D-1540-2022
Official wording
Reason: Presence of particulate matter
Code information: Lot#: EA7470, Exp 6/1/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter