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Biovail Corporation
Biovail Announces Voluntary Recall of Certain Lots of Ultram® ER 100mg Tablets
January 16th, 2009
Biovail Corporation announced a voluntary recall of certain lots of Ultram® ER (extended-release tramadol hydrochloride) 100mg tablets from pharmacies and wholesalers. Biovail is taking this action as a result of certain lots being out-of-specification by approximately 1% with respect to maximum dissolution at the eight-hour mark. This minor dissolution variance does not impact patient health or safety. Importantly, the root cause of the dissolution variance, which relates to excipients used in the coating process during the manufacturing of the tablets, has been identified and corrective measures are currently being implemented. Biovail estimates that the recall will...
Source: Health Business Week (2009-01-16)
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