Drug product
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
D-223-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68,020 vials
- Official record key
drug-enforcement:D-223-2013
Official wording
Reason: Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Code information: a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter