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.

FDA recall notice · announced February 13, 2013 · Actelion Pharmaceuticals U.s

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Reason for recall

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

Notes

Distribution: CA & VA
Lot/code information: Lot #: MA00AD5, Exp: 11/30/2014
Quantity: 3 Cartons
Status: Terminated
Products in this recall event:
- 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, (D-143-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.