Non-safety-related voluntary recall of a limited portion of Daytrana(R) (methylphenidate transdermal system) patches... ( PHILADELPHIA Dec. 3 /- Shire plc...)

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Non-safety-related voluntary recall of a limited portion of Daytrana(R) (methylphenidate transdermal system) patches announced

Date:12/3/2009

PHILADELPHIA, Dec. 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced a voluntary recall of 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.

This 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.

Physicians, patients, and caregivers who have questions about Daytrana should call Shire's Daytrana customer service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-871-7113.

Noven Pharmaceuticals, Inc. continues to manufacture and Shire continues to promote DAYTRANA in the United States. DAYTRANA is licensed globally to Shire by Noven. Shire and Noven have notified the United States Food and Drug Administration (FDA) of this voluntary action.

Shire and Noven are committed to continuing ongoing quality assurance monitoring and data analysis of DAYTRANA and may implement additional voluntary actions. Shire and Noven continue to actively pursue enhancements to DAYTRANA and are working with the FDA to implement changes intended to enhance the usability of DAYTRANA.

Daytrana lots affected by this action are:


Voluntary Recall

Strength   Count       NDC#           Lot Number(s)   
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SOURCE  Shire plc
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