Production of Banamine Temporarily Halted

Production of the popular anti-inflammatory drug Banamine (flunixin meglumine) and many other drugs manufactured by Schering-Plough Corporation was temporarily halted in May when the manufacturer signed a consent decree of permanent injunction with the Food and Drug Administration (FDA). "FDA found significant violations of the current good manufacturing practices (CGMP) regulations related to facilities, manufacturing, quality assurance, equipment, laboratories, and packaging and labeling," said an FDA release.

The company agreed to pay $500 million to the U.S. Treasury and take measures to comply with the FDA's CGMP at its New Jersey and Puerto Rico plants before production could resume at those locations.

According to an FDA release, the fine is the "largest monetary settlement in FDA history." Schering-Plough has agreed to pay up to $175 million in future profits if the company fails to adhere to the time lines established in the decree.

Ninety percent of Schering-Plough's U.S. over-the-counter and prescription drugs (for various species) are manufactured at the plants in question, according to the FDA, and 73 of these drugs (125 including line extensions and dosage forms) are affected by the consent decree.

Some clinics ordered large supplies of Banamine before the decree, and there are several generic forms of the drug manufactured by other companies. In addition, small supplies of Banamine have been released to trade since May.

Jeff Heller, an equine specialist and associate product manager for Schering-Plough Animal Health, stated that all existing Banamine underwent rigorous quality control testing before distribution, and there have been no recalls. "This is a very strong company that is committed to the horse industry," he said.

About the Author

Stephanie L. Church, Editor-in-Chief

Stephanie L. Church, Editor-in-Chief, received a B.A. in Journalism and Equestrian Studies from Averett College in Danville, Virginia. A Pony Club and 4-H graduate, her background is in eventing, and she is schooling her recently retired Thoroughbred racehorse, Happy, toward a career in that discipline. She also enjoys traveling, photography, cycling, and cooking in her free time.

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