Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count p…
- Recall date
- August 22, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0430-2017
- FDA classification
- Class II
- Brand / firm
- Noven Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide within the US
Why it was recalled
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
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) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
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