RecallDepth
Class III Terminated

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.

Company
Actelion Pharmaceuticals U.S., Inc.
Recall Initiated
January 16, 2013
Posted
February 13, 2013
Recall Number
D-143-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
3 Cartons
Firm Location
South San Francisco, CA, United States

Reason for Recall

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

Distribution

CA & VA

Lot / Code Info

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

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