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.
Reported: February 25, 2015 Initiated: October 6, 2014 #D-0389-2015
Product Description
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.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 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.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 2,500 vials.
Why was this product recalled? ▼
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 25, 2015. Severity: Critical. Recall number: D-0389-2015.
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