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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