FDA-Drug2015-06-03Class II

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

Noven Pharmaceuticals, Inc.
Hazard

Defective Delivery System: One lot exceeded the mechanical peel specification

Sold states
Nationwide
Affected count
125,340 Patches
Manufactured in
11960 Sw 144th St, Miami, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2015

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