FDA recall D-0429-2024

Product

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

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-03-04

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2024