Par Sterile Products LLC recalls Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial,…

Recall date

March 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0429-2024

FDA classification

Class I

Brand / firm

Par Sterile Products LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Presence of Particulate Matter.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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