FDA-Drug2020-04-29Class II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Noven Therapeutics, LLC
Hazard
Defective Delivery System: Out of specification for mechanical peel and shear.
Sold states
Distributed Nationwide in the US
Affected count
5,614 30-count boxes
Manufactured in
11960 Sw 144th St, N/A, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1248-2020Don't want to check this manually?
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