Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
What was recalled
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.
- Recalling firm
- Actelion Pharmaceuticals U.S., Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-143-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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