FDA-Drug2017-01-18Class II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 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 68968-5554-3.
Noven Pharmaceuticals, Inc.
Hazard
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Sold states
Nationwide within the US
Affected count
364,830 patches
Manufactured in
11960 SW 144th St, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 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 68968-5554-3.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2017Don't want to check this manually?
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