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U.S. Market: Biovail Withdraws Some Lots of Ultram ER

01-05-2009 |  18:15 hs.
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Canadian drug maker Biovail Corp. announced that they withdrew from the US market some lots of their pain killers Ultram ER 100mg tablets, after they found some lots without specific information in their label.

According to Pharmacies and Wholesalers some lots of the product of the Toronto based-Biovail Corp, generically known as Tramadol, had no “out-of-specification” by about one percent regarding “maximum dissolution at the eight-hour mark,”

The operational cost of this action will be of some 3 to 4 million dollars in the company’s end of year finance. Product substitutes will be manufactured by J&J unit PriCara.

Tramadol is a synthetic, prescription pain reliever that is similar to morphine in that it binds to opioid receptors in the brain to stop the sensation of pain. The product is covered by a technology coat known as “Smartcoat” indicated to last through the day.

Ultram ER tablets are indicated for the treatment of moderate to moderately severe chronic pain. According to Wolters Kluwer Health, U.S. sales of Ultram ER 100 mg tablets were approximately $62 million in the 12 months ended June 2008.

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