FDA Drug recall D-143-2013
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals…
- FDA Drug
- Class III
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class III recall of Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals… by Actelion Pharmaceuticals U S, citing subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-143-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-01-16 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actelion Pharmaceuticals U S |
| Distribution | CA, VA |
Product
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.
Reason
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Identifiers
| code_info | Lot #: MA00AD5, Exp: 11/30/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-143-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.