FDA-Drug2015-10-14Class II
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
Noven Pharmaceuticals, Inc.
Hazard
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Sold states
US Nationwide
Affected count
125,250 Patches
Manufactured in
11960 SW 144th St, N/A, Miami, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2016Don't want to check this manually?
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