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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

US Compounding Inc: Otic Medication Recalled for Manufacturing Process Deviations

Agency Publication Date: July 17, 2020
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Summary

US Compounding Inc. is recalling 1,600 mL of its Enrofloxacin+Ketoconazole+Triamcinolone (0.5%/1%/0.1%) otic medication delivered in 30 mL Pluronic syringes. The recall was initiated due to deviations from current Good Manufacturing Practice (cGMP) standards, which are the federal regulations that ensure products are made consistently and safely. Because this medication was produced outside of these quality standards, the safety, purity, and potency of the drug cannot be guaranteed. Consumers should contact their veterinarian or pharmacist immediately to discuss using an alternative treatment.

Risk

Manufacturing deviations can lead to products that are contaminated or have incorrect concentrations of active ingredients, potentially causing ineffective treatment or adverse reactions in the animals receiving the medication.

What You Should Do

  1. Check your medication packaging for Enrofloxacin+Ketoconazole+Triamcinolone (0.5%/1%/0.1%) Otic in Pluronic in 30 mL syringes with NDC 22200960806.
  2. Identify if your product is affected by looking for Lot number 06262020@2 or 06262020 with a 'Beyond Use Date' (BUD) of 09/24/2020.
  3. Stop using the medication on your pet immediately if it matches the identified lot numbers.
  4. Contact your veterinarian or healthcare provider to discuss the recall and arrange for an alternative medication for your animal.
  5. Return any unused portions of the medication to the pharmacy or place of purchase for a refund and contact US Compounding Inc. for further instructions.
  6. For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Enrofloxacin+Ketoconazole+Triamcinolone, 0.5%/1%/0.1%, Otic in Pluronic (30 mL syringes)
Model:
NDC 22200960806
V-0465-2020
Lot Numbers:
06262020@2 (BUD: 09/24/2020)
06262020
Date Ranges: 09/24/2020 (BUD)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86015
Status: Resolved
Manufacturer: US Compounding Inc
Manufactured In: United States
Units Affected: 1600 mL
Distributed To: Arkansas, Colorado, Oklahoma, Pennsylvania
Agency Last Updated: July 24, 2020

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