FDA Drug recall D-0429-2024
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distribute…
- FDA Drug
- Class I
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class I recall of Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distribute… by Par Sterile Products, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0429-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-04 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Par Sterile Products |
| Distribution | US |
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
Presence of Particulate Matter.
Identifiers
| code_info | Lot#: 57014; Exp, 04/30/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0429-2024%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.