FDA Drug Class II — Moderate

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3

Hazard

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Products

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals,
Brand
Noven Pharmaceuticals, Inc.
UPC
Lot: 80431 Exp. 08/17

Units Affected

182,850 patches