The U.S. Food and Drug Administration (FDA) has announced the recall of a dog medication brand due to issues with “leaking and swollen packaging.” Elanco US Inc. is voluntarily recalling approximately 42,168 boxes of its Claro dog ear medicine.
Claro, which contains florfenicol, terbinafine, and mometasone furoate, has been classified as a Class II risk by the FDA. This classification suggests that while the product may cause temporary or reversible health issues, the chances of serious health consequences are relatively low.
In contrast, a Class I status denotes a significant risk where there’s a reasonable probability that using the product could lead to severe health outcomes or even death.
The recalled Claro medication consists of ten 1 mL single-dose dropperettes and has been distributed nationwide. The affected batches bear lot numbers KV04VPA and KV04P84 (expiry October 31, 2024), as well as lot number KV050FU (expiry January 31, 2025).
According to Elanco’s website, Claro is the first FDA-approved, veterinarian-administered, single-dose treatment for canine otitis externa, which is an inflammation or infection of the outer ear canal in dogs. This condition is often painful and can cause itching and discomfort.
Common causes of otitis externa include ear mites, infections, allergies, excess moisture (like from swimming), foreign objects, or ear trauma. Dogs that have floppy ears or excessive ear hair may be more susceptible due to reduced airflow and moisture buildup.
The active ingredients in Claro—the antibacterial florfenicol, antifungal terbinafine, and steroid mometasone furoate—work together to treat this condition. However, issues with leaking packaging could allow harmful bacteria or fungi into the medicine, making it unsafe. Swollen packaging might indicate chemical changes or degradation, potentially rendering the medication ineffective or hazardous.