Drug recall D-223-2013
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.
Reason for recall
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Lots and codes
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.
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 68,020 vials
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 25, 2013
- Terminated
- October 8, 2014
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.