Biovail Corp. said on 12/31/08 it is recalling certain lots of its chronic pain drug Ultram ER because of problems with tablets dissolving, a move which will cost the Canadian drug developer more than $7 million in fourth-quarter expenses and lost revenue.
Ultram Extended-Release is approved by the Food and Drug Administration to manage chronic pain in adults who require around-the-clock pain treatment long-term. The once-daily drug steadily releases pain medication throughout the day.
Biovail said the recall does not impact patient health or safety, is related to coating the tablet during manufacturing and is being corrected.
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