Drug recall D-0389-2015
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Lots and codes
One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 2,500 vials
- Distribution
- Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 6, 2014
- Terminated
- December 15, 2016
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.