Home / Recalls / Actelion Pharmaceuticals U.S., Inc. / D-143-2013

D-143-2013 Class III Terminated

Recalled by Actelion Pharmaceuticals U.S., Inc. — South San Francisco, CA

Recall Details

Product Type: Drugs
Report Date: February 13, 2013
Initiation Date: January 16, 2013
Termination Date: July 23, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 Cartons

Product Description

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.

Distribution Pattern

CA & VA

Code Information

Lot #: MA00AD5, Exp: 11/30/2014