FDA Issues Warning Letters for Unapproved Tear Stain Removers Used in Dogs and Cats

August 29, 2014

The U.S. Food and Drug Administration is issuing warning letters today to companies manufacturing unapproved animal drugs to remove tear stains in dogs and cats. These products, including Angels’ Eyes, Angels’ Glow, Pets’ Spark, and exported products Glow Groom and Health Glow, have not been reviewed by FDA for safety and effectiveness. These tear stain removers also contain the medically important antibiotic tylosin tartrate, which is not approved for use in dogs or cats, nor for the treatment of conditions associated with tear stains. Tear stain remover products are used to treat tear staining conditions around the eyes of animals, which, in particular, is associated with a condition called epiphora, mostly in cats and dogs.

FDA has serious concerns about unapproved animal drugs. Unapproved animal drugs are not reviewed by FDA and may not meet FDA’s strict standards for safety and effectiveness.

These tear stain drug products may be subject to additional enforcement action should the products continue to be marketed, such as seizure of violative products and/or injunction against the manufacturers and distributors of the violative products.

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