Cleviprex Recalled Due to Possible Contamination

Some lots of the blood-pressure drug Cleviprex are being recalled because some vials of the drug have been found to contain visible particulate matter, the Food and Drug Administration said.

The Medicines Company, which makes Cleviprex (clevidipine butyrate), said routine testing of sample vials detected tiny pieces of stainless steel, according to the FDA recall notice. If allowed to accumulate inside the body, the contamination could result in tissue damage, acute or chronic inflammatory reactions, and reduced blood supply to tissues causing damage to the brain, kidney, liver, heart, or lungs.

Cleviprex is a dihydropyridine calcium channel blocker approved for reducing blood pressure when oral therapy is not appropriate or possible. It is delivered intravenously and the most common side effects of the drug are headache, nausea, and vomiting.

There have been no consumer complaints or reports of contamination in Cleviprex vials, but the recall has been announced to prevent injuries from occurring, officials said.

Specific Lots Recalled

There are 11 lots of Cleviprex with different expiration dates involved in the recall. They include:

 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 of the drug are affected by this recall, officials said.

Hospitals, doctors, clinics, and other healthcare providers with affected lots of Cleviprex in their inventories should arrange for its return through their pharmaceutical wholesaler/distributor, the FDA said. 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.

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