Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 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-1170-2017
- 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 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
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