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
FDA recall notice · announced April 25, 2018 · Noven Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
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
Reason for recall
Defective Delivery System: Out of specification for adhesive transfer.
Notes
Distribution: Nationwide.
Lot/code information: Lot #: 82237 Exp. May 31, 2018
Quantity: 9016 boxes of 30 patch each
Status: Terminated
Products in this recall event:
- 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 (D-0627-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.