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
FDA recall notice · announced June 3, 2015 · 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 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
Reason for recall
Defective Delivery System: One lot exceeded the mechanical peel specification
Notes
Distribution: Nationwide
Lot/code information: Lot # 73346, Exp 03/2015
Quantity: 125,340 Patches
Status: Terminated
Products in this recall event:
- 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., (D-1086-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.