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FDA Drug & Medical Device Recall News & Comments 
Friday, June 06 2008

Iloprost / Ventavis Warning

 

The FDA has announced a partial recall of Ventavis / Iloprost, a drug marketed by Actelion Pharmaceuticals US, Inc. for the treatment of Pulmonary Arterial Hypertension (PAH), or Primary Pulmonary Hypertension (PPH). The Iloprost Ventavis recall was announced after Actelion received numerous reports that some ampules of Iloprost Ventavis were empty or contained less than the full amount of Vantavis.

 

Defective Iloprost / Ventavis Recalled by FDA

 

This manufacturing defect of Ventavis / Iloprost can result in a person with PAH or PPH receiving too little medication, which can be potentially fatal. The recalled lots of Ventavis/iloprost are Lots #63228A, #63230A, #63231A and #63232A. Ventavis / Iloprost is an inhalation solution that comes in glass ampules.The incorrect amount of Ventavis / iloprost can cause serious personal injury or death to a PPH or PAH patient.

 

 

Posted by: DW AT 12:34 pm   |  Permalink   |  Email
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