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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
Medications & Supplements/Veterinary Medicines

Pegasus Laboratories, Inc.: ReBalance Antiprotozoal Oral Suspension Recalled for Potency Issues

Agency Publication Date: September 29, 2014
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Summary

Approximately 2,988 bottles of ReBalance Antiprotozoal Oral Suspension (sulfadiazine and pyrimethamine), a medication used to treat horses, are being recalled. The recall was initiated because routine stability testing at the 6-month mark showed lower than expected levels of pyrimethamine, one of the active ingredients. This means the medication may not be at full strength for the duration of its expected shelf life. If you have this product, you should contact your veterinarian or pharmacist for guidance on how to return the unused portion and obtain a replacement.

Risk

The lower-than-labeled concentration of pyrimethamine may result in the medication being less effective than intended. For horses being treated for specific protozoal infections, a reduced dose may lead to inadequate treatment of the condition.

What You Should Do

  1. Immediately check the label of your ReBalance Antiprotozoal Oral Suspension (Sulfadiazine and Pyrimethamine) to see if it matches Lot # 131110.
  2. Stop using the medication from the affected lot and contact your veterinarian or healthcare provider to discuss your horse's treatment plan and potential alternative medications.
  3. Return any unused product from Lot # 131110 to the pharmacy or place of purchase for a refund.
  4. Contact the manufacturer, Pegasus Laboratories, Inc., for further instructions regarding the return process.
  5. If you have additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002 or via email at AskCVM@fda.hhs.gov.

Your Remedy Options

💰Full 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: ReBalance Antiprotozoal Oral Suspension (Sulfadiazine and Pyrimethamine)
Model:
V-167-2014
Lot Numbers:
131110

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68998
Status: Resolved
Manufacturer: Pegasus Laboratories, Inc.
Sold By: veterinary clinics; pharmacies
Manufactured In: United States
Units Affected: 2,988 bottles
Distributed To: California, Florida, Georgia, Kentucky, Missouri, New York, Pennsylvania, Texas, Virginia

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 · Raw API Response