Drug Enforcement D-0429-2024

Presence of Particulate Matter.

Status

Ongoing

Classification

Class I

Report Date

April 3, 2024

Termination Date

—

Product Information

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
Product quantity
466 vials
Reason for recall
Presence of Particulate Matter.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
PAR Sterile Products LLC
Address
870 Parkdale Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0429-2024
Event ID
94166
Recall initiation date
March 4, 2024
Center classification date
March 28, 2024
Code info
Lot#: 57014; Exp, 04/30/2024
More code info
—