July 15, 2004

 

 Bayer receives injunction against drug compounder - July 15, 2004

Posted on July 1, 2004
 

Bayer HealthCare LLC's Animal Health Division on May 5 received a favorable court order in its lawsuit against Tabor Home Medical Services and Kalchem International Inc., both of Lindsay, Okla., for deceptive trade practices on Baytril 100.

Bayer is the only FDA-approved manufacturer of Baytril 100 (enrofloxacin) Injectable Solution and, therefore, the only legitimate source of this product. The civil action charged that Tabor and Kalchem knowingly purchased counterfeit enrofloxacin from illegal sources, manufactured unapproved material, and misrepresented the product as Baytril and Enrofloxacin to veterinarians and cattle producers.

The court order includes monetary damages in the amount of $400,000, which equals the proceeds received by Tabor and Kalchem from the sale of enrofloxacin.

In addition, the court order includes a permanent injunction prohibiting Tabor and Kalchem from buying or selling enrofloxacin.

Bayer Animal Health and the FDA will take possession of the counterfeit enrofloxacin drug substance currently on hand at Kalchem International Inc. and will see that it is properly destroyed.

John Payne, president and general manager, Bayer HealthCare LLC, Animal Health Division, said, "This permanent injunction represents a positive step in our continuing effort to address illegal activities that undermine the ethical business practices of the veterinary community. Bayer will continue to take legal action when appropriate to protect consumers, the veterinary industry, and our products."

Bayer filed the lawsuit after learning Tabor and Kalchem were advertising for sale a bulk active ingredient, "enrofloxacin," and compounded "enrofloxacin drug products."