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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Progesterone Injection Recalled for Presence of Glass Particulate Matter

Agency Publication Date: August 1, 2024
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Summary

Eugia US LLC has recalled 17,136 vials of Progesterone Injection, USP (500 mg per 10 mL). The recall was initiated following a complaint of a glass particle found inside a vial. This medication is a sterile injectable product typically administered in clinical or hospital settings.

Risk

Injecting a product containing glass particles can cause local irritation, inflammation, or serious injury if the particles travel through the bloodstream, potentially leading to blood clots in the lungs or other organs.

What You Should Do

  1. The recalled product is Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL) sold in 10 mL multiple-dose vials under NDC 55150-306-10 with lot number CPR230029A.
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, Eugia US LLC, or your distributor to arrange for the return of any remaining vials.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Clinical/hospital-administered drug return

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

Affected Products

Product: Progesterone Injection, USP (500 mg per 10 mL)
Variants: 50mg/mL, 10 mL Multiple-Dose Vial, Rx Only
Lot Numbers:
CPR230029A
NDC:
55150-306-10

Manufactured in India for Eugia US LLC, E Windsor, NJ 08520.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95059
Status: Active
Manufacturer: Eugia US LLC
Sold By: Wholesalers; Hospitals; Clinics; Surgical Centers
Manufactured In: India
Units Affected: 17136 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 ยท 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.