Drug recall D-1547-2014
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Reason for recall
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Lots and codes
Lot #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 844,300 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 2, 2014
- Terminated
- May 29, 2015
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.