Drug product
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
D-1382-2012
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 62009
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 36,125 vials; b) 31,280 vials
- Official record key
drug-enforcement:D-1382-2012
Official wording
Reason: Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Code information: Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter