Biovail recalls certain lots of Ultram ER 100mg tablets

Biovail said that it 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, the company said.

Biovail estimates that the recall will negatively impact Ultram ER revenues by $4.4m in the fourth quarter of 2008, the majority of which is expected to be recognized in the first quarter of 2009 as replacement shipments of Ultram ER 100mg tablets are made to Biovail’s marketing partner, PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals.

In addition, the voluntary recall is expected to result in inventory and administrative expenses of approximately $3m in the fourth quarter of 2008. At this time, Biovail does not anticipate any product shortages at the pharmacy level.