Treprostinil Injection — Class I drug recall D-0429-2024
Ongoing recall by Par Sterile Products LLC, reported 2024-04-03, distributed nationwide. Presence of Particulate Matter.
| Recall number | D-0429-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Sterile Products LLC, Rochester, MI, United States |
| Recall initiated | 2024-03-04 |
| Classified | 2024-03-28 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 466 vials |
| Reason classes | specification failure |
| NDC | 42023-0206-01 |
| Lot numbers | 57014 |
| Expiration dates | 2024-04-30 |
Product
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
Reason for recall
Presence of Particulate Matter.
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-0429-2024. 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.