Claro Otic Solution for Dogs Recalled for Leaking and Swollen Packaging

Agency Publication Date: October 2, 2024

Summary

ELANCO US INC is recalling approximately 42,168 boxes of Claro (florfenicol, terbinafine, mometasone furoate) Otic Solution for dogs because the dropperette packaging may be leaking or swollen. This veterinary medication, manufactured in Germany and distributed nationwide in the USA, is sold in boxes containing 10 single-dose dropperettes. Consumers should check their supply for specific lot numbers expiring in October 2024 and January 2025.

Risk

The leaking or swollen packaging may compromise the sterility or integrity of the medication, which could lead to ineffective treatment or potential ear irritation in dogs.

What You Should Do

Check your Claro Otic Solution packaging for lot numbers KV04VPA or KV04P84 with an expiration date of October 31, 2024, or lot number KV050FU with an expiration date of January 31, 2025.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or to report a problem.

Your Remedy Options

You have 2 options:

Option 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

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: CLARO (florfenicol, terbinafine, mometasone furoate), Otic Solution (10 x 1 mL)by Claro

Variants: Single dose dropperettes

Lot Numbers:

KV04VPA (Exp 31/Oct/2024)

KV04P84 (Exp 31/Oct/2024)

KV050FU (Exp 31/Jan/2025)

NADA # 141-440; Manufactured for Elanco US Inc., Shawnee, KS 66216

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95328

Status: Active

Manufacturer: ELANCO US INC

Sold By: veterinary clinics; authorized distributors

Manufactured In: Germany

Units Affected: 42,168 boxes

Distributed To: Nationwide

Agency Last Updated: October 17, 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 · Raw API Response

Summary

What You Should Do

Check your Claro Otic Solution packaging for lot numbers KV04VPA or KV04P84 with an expiration date of October 31, 2024, or lot number KV050FU with an expiration date of January 31, 2025.

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or to report a problem.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

Option 2: Dispose of Product

How to: Throw the product away.