Reported Feb 13, 2013 · Terminated

Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for…

Actelion Pharmaceuticals U.S., Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Actelion Pharmaceuticals U.S., Inc. · 5000 Shoreline Ct. Ste 200 · South San Francisco, CA · 94080-1956

Is this the product you have?

  • 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
  • NDC66215-302-30
Lot codes and dates
  • Lot #: MA00AD5
  • Exp11/30/2014
Amount recalled
3 Cartons

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 23, 2013 · Data as of Sep 19, 7:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.