FDA Recall D-0389-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 801 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0389-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- 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.
- Recall initiated
- 2014-10-06
- Classified by FDA Center
- 2015-02-13
- FDA published
- 2015-02-25
- Terminated
- 2016-12-15
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- PROPOFOL
- Generic name(s)
- PROPOFOL
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-4699, 0409-6010- Route(s)
- INTRAVENOUS