FDA-Drug2016-07-20Class 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 z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Sold states
Nationwide
Affected count
2088 boxes
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-1439-2016Don't want to check this manually?
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