Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Ventavis (iloprost) Inhalation Solution Recalled by Actelion Pharmaceuticals U.S., Inc. Due to Subpotent Drug: OOS (out of specification) assay result...

Date: January 16, 2013
Company: Actelion Pharmaceuticals U.S., Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Actelion Pharmaceuticals U.S., Inc. directly.

Affected 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.

Quantity: 3 Cartons

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: CA, VA

Affected (2 states)Not affected

About Actelion Pharmaceuticals U.S., Inc.

Actelion Pharmaceuticals U.S., Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report