D-0889-2022 Class II Ongoing

Recalled by Noven Pharmaceuticals Inc — Miami, FL

Recall Details

Product Type
Drugs
Report Date
June 1, 2022
Initiation Date
May 6, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
274, 110 patches

Product Description

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, 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: customer complaints exceeded respective action limits.

Distribution Pattern

Nationwide to the U.S. Market

Code Information

Lot: 90764 Exp. 08/2022