Drug recall D-1382-2012
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.
Reason for recall
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Lots and codes
Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Recall details
- Recalling firm
- Hospira, Inc., Lake Forest, IL
- Quantity
- a) 36,125 vials; b) 31,280 vials
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 11, 2012
- Terminated
- June 27, 2013
Related products
- Propofol – drug information
- NDC 0409-0010 Propofol · Propofol 10 mg/mL · Hospira, Inc.
- NDC 0409-4699 Propofol · Propofol 10 mg/mL · Hospira, Inc.
- NDC 0409-0501 Propofol · Propofol 10 mg/mL · Hospira, Inc.
- NDC 0409-6010 Propofol · Propofol 10 mg/mL · Hospira, Inc.
- NDC 0409-1511 Propofol · Propofol 10 mg/mL · Hospira, Inc.