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Schering-Plough halts drug production
Company pays FDA $500 million in fines for quality control violations
Kenilworth, N.J.-Schering-Plough Corp. temporarily ceased the production of three animal health products while bringing its manufacturing facilities in New Jersey and Puerto Rico up to federal code.
Banamine (flunixin megulumine), Nuflor (florfenicol) andOptimmune (.2 percent cyclosporine, USP) likely will go on back order untilthe upgrade is implemented, although a large stock currently is available,spokesman Bob Consalvo says.
The changes come as part of a Food and Drug Administration (FDA) deal,which includes $500 million in company fines for quality control violations,which have not been disclosed.
"Some of that work will require interruptions in production, asthese are sterile-made products," Consalvo says. "Back ordersare possible, but we do have product ready for trade."
As part of the agreement, the company's manufacturing plants will operateunder tighter scrutiny by FDA. Schering also agrees to have outside expertsensure manufacturing methods, procedures and controls at the plants meetFDA's quality standards.
Company officials would not speculate as to how long the improvementswould take to complete.