Ventavis — Class III drug recall D-143-2013
Terminated recall by Actelion Pharmaceuticals U.S., Inc., reported 2013-02-13, distributed in CA, VA. Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
| Recall number | D-143-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actelion Pharmaceuticals U.S., Inc., South San Francisco, CA, United States |
| Recall initiated | 2013-01-16 |
| Classified | 2013-02-01 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-07-23 |
| Distributed | CA, VA |
| Quantity | 3 cartons |
| Reason classes | potency, specification failure |
| NDC | 66215-0302-30 |
| Lot numbers | MA00AD5 |
| Expiration dates | 2014-11-30 |
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 for recall
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-143-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.