Why it was recalled
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: MA00AD5, Exp: 11/30/2014
Where it was sold
CA & VA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-143-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 16, 2013
- FDA report date
- Feb 13, 2013
- Quantity
- 3 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actelion Pharmaceuticals U.S., Inc.
Original FDA data
Every field from FDA enforcement report D-143-2013, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64151
- Address
- 5000 Shoreline Ct. Ste 200
- Code information
- Lot #: MA00AD5, Exp: 11/30/2014
- Postal code
- 94080-1956
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-143-2013
- Classification
- Class III
- Recalling firm
- Actelion Pharmaceuticals U.S., Inc.
- Product quantity
- 3 Cartons
- Termination date
- Jul 23, 2013
- Reason for recall
- Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- CA & VA
- Recall initiation date
- Jan 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 1, 2013