2008-12-30 10:29:19 -0400 (Reuters Health)
BANGALORE (Reuters) - Biovail Corp said it is voluntarily recalling certain lots of Ultram tablets, generically known as tramadol hydrochloride, and expects the total cost related to the recall to hurt fourth-quarter Ultram revenues by .4 million.
Bioval, Canada's biggest publicly traded drugmaker, decided to recall Ultram 100 mg tablets after certain lots were found to be out-of-specification by about 1 percent with respect to maximum dissolution at the 8-hour mark.
Ultram is a centrally acting synthetic opioid analgesic used to treat moderate to moderately severe chronic pain in adults who require around-the-clock pain treatment for an extended period of time.
The company added that the dissolution variance irregularity does not impact patient health or safety.