D-0294-2021 Class II Terminated

Recalled by Noven Pharmaceuticals Inc — Miami, FL

Recall Details

Product Type
Drugs
Report Date
March 10, 2021
Initiation Date
February 19, 2021
Termination Date
July 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
551,670 patches

Product Description

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in 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 68968-5553-3.

Reason for Recall

Defective Delivery System: Out of specification for mechanical peel.

Distribution Pattern

Nationwide in the USA

Code Information

Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.