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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 Vet
Pets & Animals/Pet Medications

Jurox Pty Ltd: Alfaxan (alfaxalone) Veterinary Injection Recalled for Solution Clarity Issues

Agency Publication Date: April 2, 2019
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Summary

Jurox Pty Ltd has recalled 57,100 vials of Alfaxan (alfaxalone 10 mg/mL) veterinary anesthetic injection due to an "out of specification" result for clarity discovered during stability testing. The recall affects 10 mL glass vials across two specific lots distributed to several states. This issue indicates that the medication may contain particles or changes in the liquid that could compromise the safety or effectiveness of the drug when administered to animals. Veterinary professionals should check their inventory immediately for the affected lot numbers.

Risk

The lack of solution clarity indicates the possible presence of particulates or a breakdown in the drug's formulation. Administering an injectable medication that is not clear as intended could lead to serious health complications for animals, including inflammation, vascular blockage, or reduced anesthetic efficacy.

What You Should Do

  1. Check your veterinary clinic inventory for Alfaxan (alfaxalone 10 mg/mL) in 10 mL glass vials with NDC 49480-001-01.
  2. Specifically look for lot number 25955 with an expiration date of August 2019 and lot number 27877 with an expiration date of March 2020.
  3. Immediately stop using vials from these affected lots and quarantine them to prevent further use.
  4. Contact your healthcare provider, pharmacist, or the distributor (Jurox Inc.) to report the affected product and receive instructions for returning the unused vials for a refund.
  5. Contact Jurox Pty Ltd or the U.S. distributor Jurox Inc. at 4520 Main Street, Kansas City, MO 64111, for any specific questions regarding the return process.
  6. For additional questions or to report adverse events, contact the FDA Center for Veterinary Medicine at 1-888-FDA-VETS.

Your Remedy Options

๐Ÿ’ฐFull Refund

Veterinary drug refund and guidance

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

Affected Products

Product: Alfaxan (alfaxalone 10 mg/mL) (10 mL per glass vial)
Model:
NDC: 49480-001-01
Recall #: V-0130-2019
Lot Numbers:
25955 (Exp August 2019)
27877 (Exp March 2020)
Date Ranges: August 2019, March 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82190
Status: Resolved
Manufacturer: Jurox Pty Ltd
Sold By: Jurox Inc.
Manufactured In: Australia
Units Affected: 57,100 vials
Distributed To: California, Colorado, Iowa, Missouri, Ohio, Pennsylvania, Tennessee, Wisconsin
Agency Last Updated: May 2, 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