Status
Terminated
Drug Enforcement D-143-2013
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Classification
Class III
Report Date
February 13, 2013
Termination Date
July 23, 2013
Product Information
- 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.
- Product quantity
- 3 Cartons
- Reason for recall
- Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- CA & VA
Location & Firm
- Recalling firm
- Actelion Pharmaceuticals U.S., Inc.
- Address
-
5000 Shoreline Ct. Ste 200, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-143-2013
- Event ID
- 64151
- Recall initiation date
- January 16, 2013
- Center classification date
- February 1, 2013
- Code info
- Lot #: MA00AD5, Exp: 11/30/2014
- More code info
- —