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FDA (Drug enforcement)Recalled 2014-10-06closedclass i

Hospira Inc.: 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 0409-46

Is my product affected?

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.

  • Brand PROPOFOL

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling 2,500 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (Lot #33-750-DJ, expiration date September 1, 2015) due to temperature abuse during transit. The products experienced uncontrolled temperature excursions while being shipped to The Harvard Drug Group in Livonia, Michigan.

The recalled lot remained within the distributor's control and was not distributed further to other locations. The record does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Details from the source

Reason for recall: Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. 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. Quantity: 2,500 vials Lot/code info: One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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