Shire voluntarily recalls Daytrana patches

Shire has announced a non-safety-related voluntary recall of a limited number of its Daytrana (methylphenidate transdermal system) patches.

It is recalling two batches of the patches used to treat attention-deficit hyperactivity disorder (ADHD) – lots 2750211 and 2764111.

The company reports that it is taking this measure as some patches do not meet their release liner removal specification, which could give patients and caregivers problems when removing their liners.

It adds that patches in the lots listed above can continue to be used unless the liner cannot be removed or the patches are damaged on opening.

“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”, Shire said.

“Shire will continue its ongoing quality assurance monitoring and data analysis of Daytrana and may implement future additional voluntary actions.”

It added that the patches would continue to be manufactured by Noven Pharmaceuticals and promoted by Shire.

The firms said they would continue their efforts to improve this product and work with regulatory authorities to make any necessary changes to enhance usability of the product.

Shire has and is developing a number of treatments for ADHD, including long-acting stimulant Adderall XR(mixed salts of a single-entity amphetamine product), prodrug Vyvanse (lisdexamfetamine dimesylate), SPD503 (guanfacine HCl extended release) and SPD465 (triple-bead mixed amphetamine salts).