May 01, 2020
Citing defective delivery systems, Noven Therapeutics is voluntarily recalling multiple lots of Daytrana (methylphenidate) transdermal systems, according to the April 29, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following Daytrana products, which were distributed throughout the United States:
- Daytrana patches, 10 mg over 9 hours (1.1 mg/hour), 30-count boxes (NDC 68968-5552-3) from lot 86647 (Exp. 9/20);
- Daytrana patches, 20 mg over 9 hours (2.2 mg/hour), 30-count boxes (NDC 68968-5554-3) from lot 86354 (Exp. 8/20); and
- Daytrana patches, 30 mg over 9 hours (3.3 mg/hour), 30-count boxes (NDC 68968-5555-3) from lots 86355 (Exp. 7/20), 86356 (Exp. 8/20), 86550 (Exp. 7/20), 87348 (Exp. 1/21), and 87965 (Exp. 1/21).
Noven Therapeutics initiated the recall March 31, 2020. On April 17, 2020, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. A remote possibility of serious harm also exists.
Daytrana is a prescription stimulant used to treat attention-deficit/hyperactivity disorder and narcolepsy.