Question 1

Is easOtic (hydrocortisone aceponate 1.11 mg / miconazole nitrate 15.1 mg / gentamicin sulfate 1.5 mg/ml) suspension for dogs packaged in 10 mL size canister, 1 canister per carton, Net Contents 10 mL, NDC 51311-360-10. NADA 141-330. The responsible firm name on the label is Virbac Animal Health, Fort Worth, TX 76137. recalled?

Accepted Answer

Virbac AH, Inc. has recalled 53,196 canisters of easOtic (hydrocortisone aceponate, miconazole nitrate, and gentamicin sulfate) suspension for dogs. This medication, used to treat ear infections, was found to have a lower-than-required level of gentamicin sulfate (the antibiotic component) during stability testing at the 18-month mark. This loss of potency means the product may not be as effective at fighting bacterial infections as intended. The affected product was sold in 10 mL canisters and distributed to several states including CA, FL, MI, MO, MN, OR, PA, and WI. Owners are advised to consult their veterinarian regarding continued use.

Question 2

What should I do?

Accepted Answer

Check your dog's medication to see if you have easOtic (hydrocortisone aceponate 1.11 mg / miconazole nitrate 15.1 mg / gentamicin sulfate 1.5 mg/ml) suspension in a 10 mL canister (NDC 51311-360-10). Look for Lot number 140729 with an Expiration Date of June 30, 2016 (30Jun2016) on the carton or canister label. If you have the affected lot, contact your veterinarian or healthcare provider for guidance on whether to continue use or seek an alternative treatment. Return any unused product to the veterinary clinic or pharmacy where it was purchased for a refund. Contact the manufacturer, Virbac AH, Inc., at their Fort Worth, Texas office for further instructions regarding this recall. For additional questions, you may contact the FDA’s Center for Veterinary Medicine at 1-240-402-7002.

Question 3

How do I get a refund or replacement?

Accepted Answer

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

Virbac AH, Inc: easOtic Suspension for Dogs Recalled for Decreased Antibiotic Potency

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

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