April 26, 2018
Noven Pharmaceuticals Inc. is recalling 9016 boxes of Daytrana (methylphenidate) transdermal patches (NDC 68968-5552-3), 10 mg over 9 hours (1.1 mg/hour). According to the April 25, 2018, US Food and Drug Administration (FDA) Enforcement Report, the medication delivery system is defective.
The recall affects 30-patch boxes from lot 82237, which expire May 31, 2018. The patches, manufactured by Noven Pharmaceuticals for Noven Therapeutics, were distributed across the United States.
Noven Pharmaceuticals voluntarily initiated the recall April 9, 2018. On April 13, 2018, the FDA designated the recall Class II, signaling use of the medication could cause temporary or medically reversible harm. The likelihood of serious harm, however, is remote.
Daytrana is a prescription stimulant used to treat children with attention-deficit/hyperactivity disorder.
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here