(Correction: Original article incorrectly said the recall was related to safety issues. A correct version follows.)
Specialty biopharmaceutical company Shire Pharmaceuticals Group plc (SHP.L,SHPGY), Thursday, announced a voluntary recall of five lots and voluntary market withdrawal of one lot of the Attention-Deficit/Hyperactivity Disorder patch Daytrana for children aged 6 to 12 years.
The company noted the mentioned Daytrana patches do not meet or in the future may not meet their release liner removal specification. Shire added that the action is not due to safety issues.
The lots that are recalled are 20 mg patch with lot numbers 33988, 34174, 34175 and 30 mg patch with lot numbers 33990, 34179, both expiring on December 31, 2010. The 30 mg patch with lot number 33991 with the same expiry date is withdrawn as well.
The company added that its Daytrana patches can still be used unless the release line cannot be removed or the patches are damaged while being opened. The patches supply is sufficient, Shire said, that patients can have their prescriptions filled at their local pharmacy.
Shire along with Noven Pharmaceuticals, the patch manufacturer, is currently working with the FDA to implement changes intended to enhance the usability of Daytrana.
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