D-0429-2024 Class I Ongoing

Recalled by Par Sterile Products LLC — Rochester, MI

Recall Details

Product Type
Drugs
Report Date
April 3, 2024
Initiation Date
March 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
466 vials

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot#: 57014; Exp, 04/30/2024