US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 31, 2013 (14 years ago)

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

What was recalled

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.

Recalling firm
Noven Pharmaceuticals, Inc.
NDC code
68968-5552-3
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-312-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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