FDA-Drug2021-06-02Class II
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Noven Pharmaceuticals Inc
Hazard
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Sold states
Nationwide in the USA
Affected count
9,587 boxes
Manufactured in
11960 Sw 144th St, N/A, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2021Don't want to check this manually?
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