FDA-Drug2022-12-07Class II
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Noven Pharmaceuticals Inc
Hazard
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Sold states
Nationwide in the USA
Affected count
3977 boxes
Manufactured in
11960 Sw 144th St, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0071-2023Don't want to check this manually?
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