FDA-Drug2017-09-27Class II

Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3

Noven Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide.
Affected count
234,960 patches
Manufactured in
11960 SW 144th St, N/A, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1172-2017

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