Drug & medication recalls Moderate risk

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manu…

Recall date
August 30, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1169-2017
FDA classification
Class II
Brand / firm
Noven Pharmaceuticals, Inc.
Sold / distributed
Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3

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