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NJ Drug Company Recalls Cleviprex due to Metal Particles

By Paul Napoli

December 16, 2009

The Medicines Company of Parsippany, NJ announced a voluntarily recall of eleven lots of Cleviprex® (clevidipine butyrate) injectable emulsion because a routine annual inspection found the medication vials to contain a visible particulate matter.

Cleviprex is an intravenous medication in a group of drugs called calcium channel blockers. Physicians use Cleviprex to control high blood pressure (hypertension) of patients who cannot take medicine by mouth in situations such as surgery, emergency or critical care departments.

The recalled Cleviprex may contain what the pharmaceutical company identified as tiny 'inert' stainless steel particles of around 2.5 microns.

"Although aggregates have not been observed, if the sub-visible 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," the Medicines Company press release said.

The company advises anyone with inventory from the affected lots of Cleviprex to return the product to their pharmaceutical wholesaler/distributor. In a letter to healthcare professionals, the company instructs those using Cleviprex, to be sure to follow these procedures: Before use, inspect the vial to look for visible particulate matter. If there is any visible particulate matter, do not use the vial. Put it aside and return it to The Medicines Company.

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.

If you or a loved one has suffered adverse reactions resulting from Cleviprex or other prescription medication, please contact the attorneys of Napoli Bern Ripka, LLP at 1-888-529-4669. Our law firm has helped so many people who have become victims of recalled medications. The consultation is free; just call 1-888-529-4669.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on December 20, 2009 (boomark / email).