Alerts
Clevidipine Butyrate Injection (Cleviprex) - Recall
March 19, 2010
The Medicines Company has expanded their recall of clevidipine butyrate to include 4 additional lots. In December, 2009, the company announced the recall of 11 lots of clevidipine butyrate injection because stainless steel particles were found in the lipid emulsion. The particles pose a potential safety issue that could result in patient harm if the particles aggregate or if larger particles are present.
The affected products are:
Lot 61-978-DW, Expiration 01/2010
Lot 61-979-DW, Expiration 01/2010
Lot 61-980-DW, Expiration 01/2010
Lot 68-404-DJ, Expiration 08/2010
Lot 68-405-DJ, Expiration 08/2010
Lot 68-406-DJ, Expiration 08/2010
Lot 68-407-DJ, Expiration 08/2010
Lot 68-408-DJ, Expiration 08/2011
Lot 69-830-DJ, Expiration 03/2011
Lot 63-385-DJ, Expiration 03/2011
Lot 63-386-DJ; Expiration 03/2011
Lot 63-266-DJ, Expiration 03/2011
Lot 64-453-DJ, Expiration 04/2011
Lot 71-101-DJ, Expiration 11/2011
Lot 71-106-DJ, Expiration 11/2011
Hospitals may return the recalled product through their wholesaler or distributor. The Medicines Company has no available product for shipment.
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194585.htm - Company Press Release – March 17 2010:
http://www.fda.gov/Safety/Recalls/ucm204997.htm - Company Press Release – December 16, 2009:
http://www.fda.gov/Safety/Recalls/ucm194555.htm
Updated
March 19, 2010; December 18, 2009; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT
