Personal Injury Law

Cleviprex, popular blood pressure drug, recalled by Medicines Company

By LaBovick Law

The Medicines Company (NASDAQ: MDCO) has issued a voluntarily recall of eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter.

The affected Cleviprex lots are 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. No other lots are affected by this recall.

The Medicines company is cooperating with the U.S. Food and Drug Administration on this recall.
The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns.
There are no known complaints or reports of adverse events related to this issue regarding Cleviprex ®

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 cleviprexrecall@themedco.com

Consumers with any adverse reactions associated with the use of Cleviprex may also report this 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.

The stock for MDCO closed at $8.04, down .08 shares from previous trading.
 

Full post as published by LaBovick Injury Law Blog on January 06, 2010 (boomark / email).