Medicines Company Recalls Specific Lots of CCB Cleviprex

Shelley Wood

Disclosures

December 16, 2009

December 16, 2009 (Parsippany, New Jersey) — The Medicines Company has announced it is voluntarily recalling specific lots of its calcium-channel blocker Cleviprex (clevidipine butyrate injectable emulsion) after finding tiny particles of stainless steel in the drug [1].

These particles are "subvisible" and inert, according to a press release issued today. The particles measure around 2.5 µm in size and were seen during a routine annual inspection.

No complaints or reports of adverse events about the product have been registered with the Medicines Company, which says it is cooperating with the FDA on the recall.

"When present in low numbers as observed, particles of this size are not known to constitute a health hazard," the press release notes. "Experimental animal and human data indicate that they are scavenged by macrophages and other cells of the reticuloendothelial system without adverse effects." That said, the release continues, "Although aggregates have not been observed, if the subvisible particles were to aggregate or if larger particles were present, then they could become visible and 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."

Eleven lots of the drug are included in the recall: 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 release notes.

Details on how to return drug affected by the recall are in the press release.

Cleviprex, an injectable emulsion, is indicated for blood-pressure lowering in patients in whom oral medications are not feasible or desirable.

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