Dog medicine recall update as FDA sets risk class

A brand of dog medicine has been recalled due to “leaking and swollen packaging,” the U.S. Food and Drug Administration (FDA) has announced.

Some 42,168 boxes of the Claro dog ear medicine, made by Elanco US Inc., have been voluntarily recalled by the company.

The Claro (florfenicol, terbinafine, mometasone furoate) Otic Solution for use in dogs only medication has now been given a Class II risk classification by the FDA.

A class II risk level is given in “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA website reads.

More hazardous product recalls are given a Class I status, which is issued in “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

The recalled product contains ten 1 mL single dose dropperettes of the medicine, and was distributed across the U.S. Affected batches have lot numbers KV04VPA and KV04P84 with an expiry date of October 31, 2024, and lot number KV050FU with expiry date January 31, 2025.

Newsweek has contacted Elanco for comment via email.

“Claro is the first FDA-approved, veterinarian-administered, single-dose treatment regimen for canine otitis externa,” Elanco says on its website.

Canine otitis externa is an inflammation or infection of the outer ear canal in dogs, usually affecting the ear flap and the external ear canal, and often causing pain, itching, and discomfort.

Causes of otitis externa in dogs can include ear mites, bacterial or yeast infections, allergies, excessive moisture in the ear (often from swimming), foreign bodies, or trauma to the ear. Dogs with floppy ears or those with excessive hair in their ears are more prone to developing this condition due to reduced airflow and increased moisture.

The Claro Otic Solution contains the antibacterial florfenicol, antifungal terbinafine, and steroid medication mometasone furoate.

Leaking packaging could allow bacteria, fungi, or other contaminants to enter the medicine, which can make it unsafe for consumption or use. Swollen packaging could also indicate chemical reactions or degradation of the medicine inside, making it less effective or even harmful.

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