A class II risk level is given to products that 'may cause temporary or medically reversible adverse health consequences.'
A brand of dog medicine has been recalled due to 'leaking and swollen packaging,' the U.S. Food and Drug Administration 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 Otic Solution for use in dogs only medication has now been given a Class II risk classification by the FDA.
'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.
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