Drug 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.
D-143-2013
Product summary
- Event
- Event 64151
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 Cartons
- Official record key
drug-enforcement:D-143-2013
Official wording
Reason: Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Code information: Lot #: MA00AD5, Exp: 11/30/2014
Distribution pattern: CA & VA
Derived failure modes
-
Potency or specification failure
Subpotent