FDAnews Drug Daily Bulletin

Shire is recalling more of its Daytrana patches for attention deficit hyperactivity disorder, possibly leading to the return of as many as 469,000 patches. Shire recently recalled 344,000 patches due to the same problem — difficulty in removing the release liner from the patch. Shire said it was getting close to implementing a long-term corrective action for the problem. The company estimates that this latest recall could cost anywhere from $1 million to $7 million, depending on how many patches actually are returned. Noven, Shire’s partner, would not give details of the root cause of the problem but said the solutions involve changes in the manufacturing process, not to the product’s formulation.