March 2024 FDA Recall Drug by Par Sterile Products Llc
D-0429-2024 - Presence of Particulate Matter.

This Class I drug recall was voluntarily initiated by Par Sterile Products Llc on March 4, 2024 for the product Drug. The FDA reported the reason for recall as presence of particulate matter.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0429-2024

Reason for Recall
Presence of Particulate Matter.
Initiated
03-04-2024
Reported
04-03-2024
Quantity
466 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94166
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Par Sterile Products LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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