Par Sterile Products LLC: Drug Recall

Recall #D-0429-2024 · 03/04/2024

Class I: Dangerous

Recall Details

Recall Number: D-0429-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Par Sterile Products LLC
Status: Ongoing
Date Initiated: 03/04/2024
Location: Rochester, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 466 vials

Reason for Recall

Presence of Particulate Matter.

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Par Sterile Products LLC

Class II: Risk 01/11/2024

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II: Risk 11/09/2021

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

View all recalls by Par Sterile Products LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.