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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 Vet
Pets & Animals/Pet Medications

Fort Dodge Laboratories Inc: Factrel (gonadorelin hydrochloride) Recalled for Low Potency Results

Agency Publication Date: March 28, 2006
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Summary

Fort Dodge Laboratories Inc is recalling approximately 194,956 vials of Factrel (gonadorelin hydrochloride) sterile solution, a prescription medication used in animals. The recall involves about 181,331 of the 20-ml multi-dose vials and 13,625 of the 50-ml multi-dose vials. This recall was initiated because the product showed assay results that were either out of specification or trending out of trend, meaning the medication may not contain the exact concentration of active ingredient required for effective treatment.

Risk

The medication failed to meet potency standards during testing, which could lead to animals receiving an incorrect dose of gonadorelin. This may result in the drug being less effective than intended for its clinical use.

What You Should Do

  1. Check your animal health supplies for Factrel Gonadorelin Hydrochloride (50 mcg/mL) in 20-ml or 50-ml multi-dose vials with NDC 0856-4311-02 or NADA 139-237.
  2. Verify the label for the manufacturer names 'Fort Dodge Animal Health' or 'Ayerst Veterinary Laboratories' to see if your product is included in this recall.
  3. Contact your veterinarian or pharmacist immediately to discuss the use of this product and to determine if your specific lot is affected.
  4. Return any unused vials of the recalled medication to the pharmacy or veterinarian's office where you purchased it for a refund.
  5. Contact Fort Dodge Laboratories Inc for further instructions regarding the return and replacement process.
  6. For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Veterinary medication refund/consultation

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

Affected Products

Product: Factrel Gonadorelin Hydrochloride, 50 mcg/mL Sterile Solution (20-ml)
Model:
NADA 139-237
NDC 0856-4311-02
Product: Factrel Gonadorelin Hydrochloride, 50 mcg/mL Sterile Solution (50-ml)
Model:
NADA 139-237

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 34366
Status: Resolved
Manufacturer: Fort Dodge Laboratories Inc
Sold By: Fort Dodge Animal Health; Ayerst Veterinary Laboratories
Manufactured In: United States
Units Affected: 181,331/20-ml vials and 13,625/50-ml 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