FDA Drug Class III — Least Serious

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.

Hazard

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

Products

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,
Brand
Actelion Pharmaceuticals U.S., Inc.
UPC
Lot #: MA00AD5, Exp: 11/30/2014

Units Affected

3 Cartons