Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactur…
- Recall date
- July 27, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0008-2016
- FDA classification
- Class II
- Brand / firm
- Noven Pharmaceuticals, Inc.
- Sold / distributed
- US Nationwide
Why it was recalled
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
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), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
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