Product: 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.
Reason for recall: Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Recall initiated: 20130116
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated