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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: MA00AD5, Exp: 11/30/2014
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Actelion Pharmaceuticals U.S., Inc.
Reason for Recall:
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: CA, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-143-2013