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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Par Sterile Products LLC 2024-04-03 Health critical FDA
Health · FDA · Recall #FDA-D-0429-2024

Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion… Recall

Issued April 3, 2024 · Par Sterile Products LLC

In April 2024, Par Sterile Products LLC recalled the Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Presence of Particulate Matter.

What you should do

  1. 1 Stop using Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Par Sterile Products LLC to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Par Sterile Products LLC
Category
Health
Recall date
April 3, 2024
Units affected
Not reported
Sold at
Nationwide in the USA
Recall number
FDA-D-0429-2024
Made in
United States
Issuing agency
FDA

In context

  • Par Sterile Products LLC has 2 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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