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FDAFDA · Food and drugs·Recall number D-0389-2015

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.

Published February 25, 2015 · Recall initiated: October 6, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

What to do

Voluntary: Firm initiated · Telephone

Recall details

Brand
PROPOFOL
Manufacturer
Hospira Inc.
Distributor
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.
Lot
One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI
Risk classification
Class I
Area (FDA)
drug
Country
United States

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