FDA-Drug2018-04-25Class II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Noven Pharmaceuticals, Inc.
Hazard
Defective Delivery System: Out of specification for adhesive transfer.
Sold states
Nationwide.
Affected count
9016 boxes of 30 patch each
Manufactured in
11960 SW 144th St, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2018Don't want to check this manually?
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