FDAClass IIIFebruary 13, 2013

Ventavis recall: Subpotent

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

Why was Ventavis recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: MA00AD5, Exp: 11/30/2014

Product
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc…
Recalling firm
Actelion Pharmaceuticals U.S., Inc.
Quantity
3 Cartons
Distribution
CA & VA
Recall date
February 13, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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