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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Treprostinil Injection Recalled for Presence of Particulate Matter

Agency Publication Date: March 28, 2024
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Summary

Par Sterile Products LLC is recalling 466 vials of Treprostinil Injection, 20 mg/20 mL (1 mg/mL), due to the presence of particulate matter. This medication is used for subcutaneous or intravenous infusion and was distributed nationwide. Injecting a product containing foreign particles can lead to serious health complications, such as blood vessel blockages or inflammation.

Risk

The presence of particulate matter in an injectable drug poses a risk of vascular occlusion, embolism, or inflammatory reactions. These particles can cause local irritation or systemic damage if they travel through the bloodstream.

What You Should Do

  1. This recall affects Treprostinil Injection, 20 mg/20 mL (1 mg/mL), in 20 mL multiple-dose vials with NDC 42023-206-01, lot number 57014, and an expiration date of 04/30/2024.
  2. Stop using the recalled product. Contact the manufacturer, Par Sterile Products LLC, or your distributor to arrange for the return of any remaining vials.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Treprostinil Injection (20 mg/20 mL)
Variants: 20 mg/20 mL (1 mg/mL), 20 mL Multiple-Dose Vial
Lot Numbers:
57014 (Exp 04/30/2024)
NDC:
42023-206-01

Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977.

Product Images

Label, Par Pharmaceutical Treprostinil 20mg/20mL Injection.

Label, Par Pharmaceutical Treprostinil 20mg/20mL Injection.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94166
Status: Active
Manufacturer: Par Sterile Products LLC
Manufactured In: United States
Units Affected: 466 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.