PHILADELPHIA, June 9 /PRNewswire-FirstCall/ -- Shire Limited (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced today a voluntary recall of two (2) lots of the ADHD patch DAYTRANA (lots 2750211 and 2764111). Shire is taking this action because some DAYTRANA patches do not meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners. This voluntary recall is not due to safety issues.
Because this voluntary recall is not due to product safety issues, all DAYTRANA patches, including those in the lots listed above, 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, Inc. continues to manufacture and Shire continues to promote this product in the United States.
Shire will continue its ongoing quality assurance monitoring and data analysis of DAYTRANA, and may implement future additional voluntary actions. Shire and Noven continue to actively pursue enhancements to this product, and to work closely with the United States Food and Drug Administration (FDA) to implement changes that may enhance the usability of DAYTRANA.
Physicians, patients and caregivers who have questions regarding DAYTRANA should call Shire's DAYTRANA customer service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-879-8218.
DAYTRANA is licensed globally to Shire by Noven. Shire and Noven have notified the FDA of this voluntary recall.
Notes to editors
Important Safety Information
Tell your doctor about any heart conditions, including structural
abnormalities, your child or a family member may have. Inform your doctor
immediately if the child develops symptoms that sugges
|SOURCE Shire Limited|
Copyright©2008 PR Newswire.
All rights reserved