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Biovail recalls some Ultram ER lots

Biovail recalls some Ultram ER lots

Canadian drugmaker Biovail Corp. is recalling an unspecified amount of its Ultram extended-release pain medication, citing a minor variance in the rate at which the pills dissolve, the company said Tuesday.
The move will cost Canada's largest publicly traded drug maker more than US$7 million in fourth-quarter expenses and lost revenue, Biovail said.
Specifically, the recall from pharmacies and wholesalers is expected to cut quarterly revenue by $4.4 million, while adding $3 million to inventory and administrative costs.
The company said it decided to recall certain lots of 100-milligram Ultram ER after discovering the lots have a minor variance in the rate at which the pills dissolve.
"Biovail is taking this action as a result of certain lots being out-of-specification by approximately 1 percent with respect to maximum dissolution at the eight-hour mark," the company said in a news release Tuesday.
The Toronto-based company said that the recall does not impact patient health or safety.
The company's statement attributed the problem to excipients _ inactive substances that carry active ingredients _ used in the coating process. The company said it was taking measures to correct the problem.


Updated : 2021-08-01 18:19 GMT+08:00