Drug recall D-0293-2021

Class II Terminated reported Mar 10, 2021

Product

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3.

Reason for recall

Defective Delivery System: Out of specification for mechanical peel.

Lots and codes

Lots #: 87579, Exp 3/2021 & 88243, Exp 7/2021.

Recall details

Recalling firm
Noven Pharmaceuticals Inc, Miami, FL
Quantity
473,280 patches
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 19, 2021
Terminated
July 5, 2024

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