FDA-Drug2013-02-13Class III

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.

Actelion Pharmaceuticals U.S., Inc.
Hazard

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

Sold states
CA & VA
Affected count
3 Cartons
Manufactured in
5000 Shoreline Ct. Ste 200, N/A, South San Francisco, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-143-2013

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