Shire has recalled five lots and voluntary market withdrawal of one lot of the attention-deficit/hyperactivity disorder (ADHD) patch Daytrana.
Shire is taking this action because some Daytrana patches do not meet or in the future may not meet their release liner removal specification, and as a result, patients and caregivers could have difficulty removing the liners.
The company said that the action is not due to safety issues. All Daytrana patches can continue to be used unless the release liner cannot be removed or the patches are damaged while being opened. The current supply levels of Daytrana should be sufficient to ensure that patients can continue to have their Daytrana prescriptions filled at their local pharmacy.
Noven Pharmaceuticals (Noven) continues to manufacture and Shire continues to promote Daytrana in the US. Daytrana is licensed globally to Shire by Noven. Shire and Noven have notified the FDA of this voluntary action.
Both the companies continue to actively pursue enhancements to Daytrana and are working with the FDA to implement changes intended to enhance the usability of Daytrana.