ADHD Patches Recalled

Noven Pharmaceuticals Inc is recalling more than 15,000 boxes of Daytrana (methylphenidate transdermal system) patches because of defective delivery systems. “The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits,” stated the June 2, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes 30-count boxes of the following products, which were manufactured for Noven Therapeutics, LLC, Miami, FL, by Noven Pharmaceuticals, Inc, Miami, FL, and distributed within the United States:

• Daytrana patches, 10 mg over 9 hours (1.1 mg/hour; NDC 68968-5552-1, box NDC 68968-5552-3), from lot 88528 (Exp. 9/21); and
• Daytrana patches, 15 mg over 9 hours (1.6 mg/hour; NDC 68968-5553-1, box NDC 68968-5553-3), from lot 88530 (Exp. 10/21). 

Noven Pharmaceuticals voluntarily initiated the recall May 20, 2021. The FDA designated the recall Class II on May 24, 2021. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Daytrana is a prescription stimulant used to treat attention-deficit/hyperactivity disorder.