← FDA ENFORCEMENT
D-0429-2024Class I

Par Sterile Products LLC

Recalling firm
Par Sterile Products LLC
Product type
Drug
Status
Ongoing
Report date
2024-04-03
Distribution
Nationwide in the USA
Firm state
MI
Product quantity
466 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.