Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.

Recall Number: D-143-2013

Firm: Actelion Pharmaceuticals U.S., Inc.

Classification: Class III

Status: Terminated

Report Date: 20130213

Initiation Date: 20130116

Termination Date: 20130723

Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.

Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.