January 2015 FDA Recall Daytrana by Noven Pharmaceuticals, Inc.
D-1086-2015 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Noven Pharmaceuticals, Inc. on January 12, 2015 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-1086-2015
Defective Delivery System: One lot exceeded the mechanical peel specification
01-12-2015
06-03-2015
125,340 Patches
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-19-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
Batch or Lot Expiration Information
Lot# 73346, Exp 03/2015
