April 2018 FDA Recall Daytrana by Noven Pharmaceuticals, Inc.
D-0627-2018 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Noven Pharmaceuticals, Inc. on April 9, 2018 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-0627-2018
Defective Delivery System: Out of specification for adhesive transfer.
04-09-2018
04-25-2018
9016 boxes of 30 patch each
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.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Batch or Lot Expiration Information
Lot# : 82237 Exp. May 31, 2018
