Cleviprex Recall Issued Due to Stainless Steel Particles

The FDA announced a recall of Cleviprex on Thursday, indicating that certain lots of the hypertension drug may be contaminated with stainless steel particles that could reduce blood flow and lead to potentially lead to serious injury.

Cleviprex (clevidipine butyrate) is an intravenously-delivered drug used to reduce blood pressure, manufactured by The Medicines Company. The Cleviprex recall was issued after visible particles were found in vials during an annual inspection.

“If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions,” warned the FDA in a statement posted December 17, 2009. “Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.”

There have been no injuries reported in association with the contaminated Cleviprex vials.

The recall affects the following 11 lots of Cleviprex injectable emulsion: 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 recall is limited to these lots.

Any health care professionals with recalled lots of Cleviprex in their inventory should return the product to the pharmaceutical distributor or wholesaler where it was purchased. The Medicines Company is currently shipping additional batches from unaffected lots to wholesalers.

Any adverse reactions from the use of Cleviprex should be reported to the FDA’s MedWatch Program at www.fda.gov/medwatch.