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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

PCCA Ronidazole Recalled for Manufacturing Quality and Solvent Issues

Agency Publication Date: August 13, 2024
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Summary

Professional Compounding Centers of America (PCCA) is recalling various sizes of Ronidazole (1kg/kg strength), a veterinary drug component repackaged in July 2024. The recall was initiated because the product was manufactured in a non-classified area without a proper HVAC system and was found to have an out-of-specification residual solvent. This is a downstream recall following a broader recall by the original active pharmaceutical ingredient (API) supplier.

Risk

Manufacturing in an unclassified environment without proper air filtration and the presence of improper levels of residual solvents can lead to product contamination or inconsistent drug potency, which may pose a risk to animal health.

What You Should Do

  1. Check your Ronidazole packaging for Lot Numbers C200624 (Exp 11/30/2024), C202963 (Exp 08/31/2025), C204286 (Exp 08/31/2025), or C206283 (Exp 10/31/2026) and UPC 624643079348.
  2. If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions or to report issues.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: PCCA Ronidazole (various sizes)
Variants: 5gm, 25gm, 100gm, 1000gm, 1kg/kg strength
Model:
30-3814
UPC Codes:
624643079348
Lot Numbers:
C200624 (Exp 11/30/2024)
C202963 (Exp 08/31/2025)
C204286 (Exp 08/31/2025)
C206283 (Exp 10/31/2026)
NDC:
51927-3814-0

Packaged on: Jul 2024; For Veterinary Use Only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95092
Status: Resolved
Manufacturer: Professional Compounding Centers of America dba PCCA
Sold By: Professional Compounding Centers of America (PCCA)
Manufactured In: United States
Distributed To: Nationwide
Agency Last Updated: August 26, 2024

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