March 27, 2020
Noven Therapeutics is recalling more than 40,000 boxes of Daytrana (methylphenidate transdermal system) patches because of delivery system defects. According to the March 25, 2020, US Food and Drug Administration (FDA) Enforcement Report, the patches do not meet specifications for mechanical peel and shear.
The recall includes 30-count boxes of the following Daytrana products:
- Daytrana patches, 10 mg over 9 hours (1.1 mg/hour, NDC 68968-5552-3), from lot 86280 (Exp. 6/20);
- Daytrana patches, 15 mg over 9 hours (1.6 mg/hour, NDC 68968-5553-3), from lots 85942 (Exp. 3/20) and 86281 (Exp. 6/20);
- Daytrana patches, 20 mg over 9 hours (2.2 mg/hour, NDC 68968-5554-3), from lots 86081 (Exp. 4/20) and 86196 (Exp. 6/20); and
- Daytrana patches, 30 mg over 9 hours (3.3 mg/hour, NDC 68968-5555-3), from lots 86083 (Exp. 5/20) and 86282 (Exp. 6/20).
The patches were distributed throughout the United States.
Noven Therapeutics voluntarily initiated the recall March 2, 2020. On March 19, 2020, the FDA designated the recall Class II. Medications 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.