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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

AuroMedics Pharma LLC: Fluphenazine Decanoate Injection Recalled for Discoloration and Hazy Solution

Agency Publication Date: November 29, 2019
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Summary

AuroMedics Pharma LLC has voluntarily recalled 59,500 vials of Fluphenazine Decanoate Injection USP (125mg/5mL). This prescription medication is being recalled because one vial was found to contain a hazy solution and discoloration instead of the required clear liquid. Using a drug that is discolored or cloudy can lead to serious health complications, such as vein inflammation or blockages, and consumers should contact their healthcare provider or pharmacist immediately for guidance.

Risk

A hazy or discolored solution indicates a potential chemical or physical change in the medication that could cause severe irritation, inflammation of the veins, or the formation of particles that could block blood flow if injected.

What You Should Do

  1. Identify your medication by checking the vial or packaging for Fluphenazine Decanoate Injection USP 125mg/5mL in 5 mL Multiple Dose Vials.
  2. Check the vial for lot number CFD190004 with an expiration date of August 2020.
  3. Immediately stop using any vials from the affected lot and contact your healthcare provider or pharmacist to discuss alternative treatments.
  4. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact AuroMedics Pharma LLC directly for further instructions regarding the return or disposal of the product.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fluphenazine Decanoate Injection USP 125mg/5mL (5 mL Multiple Dose Vial)
Model:
Recall #: D-0609-2020
Lot Numbers:
CFD190004 (Exp August 2020)
Date Ranges: August 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84244
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Sold By: wholesalers; distributors
Manufactured In: United States, India
Units Affected: 59,500 vials
Distributed To: Nationwide
Agency Last Updated: December 9, 2019

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.