FDAFDA · Food and drugs·Recall number D-143-2013
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.
Published February 13, 2013 · Recall initiated: January 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actelion Pharmaceuticals U.S., Inc.
- Distributor
- CA & VA
- Lot
- Lot #: MA00AD5, Exp: 11/30/2014
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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