Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 ...
FDA Recall #D-0429-2024 — Class I — March 4, 2024
Product 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
Reason for Recall
Presence of Particulate Matter.
Recalling Firm
Par Sterile Products LLC — Rochester, MI
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
466 vials
Distribution
Nationwide in the USA
Code Information
Lot#: 57014; Exp, 04/30/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated