Recall for Certain Lots of Cleviprex
The Medicines Company Expands a Nationwide Recall for Certain Lots of Cleviprex That May Contain Particulate MatterMarch 17, 2010 - Parsippany, N.J. - The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily expanding the recall of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials. Four (4) additional lots of Cleviprex are being recalled. The four additional Cleviprex lots are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011. The previously recalled lots were 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. The Company is cooperating with the U.S. Food and Drug Administration on this recall.
The visible particulate matter is primarily made up of sub visible inert stainless steel particles of around 2.5 microns in diameter. Experimental animal and human data indicate that these particles are scavenged by macrophages and other cells of the reticuloendothelial system. Particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.
Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor.
For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or firstname.lastname@example.org.
Any adverse reactions associated with the use of Cleviprex may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
U.S. Food and Drug Administration
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