Cleviprex Recalled For Particulate Matter

The Medicines Company just announced that it is voluntarily recalling 11 lots of <"">Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which was observed in some vials during a routine annual inspection, the U.S. Food and Drug Administration (FDA) said.

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;
• 64-453-DJ: Exp. 04/2011

No other lots are affected by this recall.

To date, the Medicines Company has not received any product complaints or reports of adverse events related to this issue.

The FDA explained that particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns. When this matter is present in low numbers, as is the case in this recall, particles of this size are not known to lead to a health hazard. If these sub-visible particles were to combine, or if larger particles are present, they could become visible and could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. A reduced blood supply to tissues could 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. Unaffected product from lots 68-407-DJ, 68-408-DJ, 71-101-DJ and 71-106-DJ is being shipped to wholesalers and can be ordered by hospitals.

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information toll-free at 1-888-977-6326 Monday to Friday 8:00 am to 5:30 pm Eastern Standard Time or by email at:

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

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