Drug recall D-1685-2012
Product
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), 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 and confirmed in sample bottles of the recalled lots during retain inspection.
Lots and codes
Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 148,630 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 29, 2012
- Terminated
- August 8, 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.