TREPROSTINIL Recall D-0429-2024
Description: 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
TREPROSTINIL Recall D-0429-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0429-2024 |
| Event ID | 94166 |
| Brand | TREPROSTINIL |
| Generic Name | TREPROSTINIL |
| Manufacturer | TREPROSTINIL |
| Original Package? | 1 |
| Active Substance | TREPROSTINIL |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 466 vials |
| Recall Reason | Presence of Particulate Matter. |
| Drug Classification | Class I |
| Drug Code Info | 20240403 |
| Product NDC | 42023-206 42023-209 42023-208 |
| Product NUI | N0000175416 M0017817 N0000009909 |
| Pharma Class (PE) | Vasodilation [PE] |
| Pharma Class (EPC) | Prostacycline Vasodilator [EPC] |
| Pharma Class (CS) | Prostaglandins I [CS] |
| Recall Initiation Date | 20240304 |
| Report Date | 20240403 |
| Classification Date | 20240328 |
| Address | 870 Parkdale Rd Rochester, MI 48307-1740 United States |
| Recalling Firm | Par Sterile Products LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | RUM6K67ESG |
| Drug Application Number | ANDA209382 |
| Structured Product Labeling (SPL ID) | 1798515a-9b6d-4718-b259-8f893c14b904 |
| Structured Product Labeling (SPL Set ID) | f251795d-aba6-4762-bdd9-477daab6e9a7 |
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