January 2013 FDA Recall Daytrana by Noven Pharmaceuticals, Inc.
D-312-2013 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Noven Pharmaceuticals, Inc. on January 31, 2013 for the product Daytrana. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-312-2013

Reason for Recall
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.
Initiated
01-31-2013
Reported
05-08-2013
Quantity
335,910 patches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64710
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Noven Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2016
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 59824, Exp 04/13

Affected Packages Involved in this Recall

68968-5552-3 Daytrana
68968-5553-3 Daytrana
68968-5554-3 Daytrana
68968-5555-3 Daytrana