D-0295-2021 Class II Terminated
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
- 786,900 patches
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 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 68968-5554-3.
Reason for Recall
Defective Delivery System: Out of specification for mechanical peel.
Distribution Pattern
Nationwide in the USA
Code Information
Lots #: 87580, Exp 4/2021, 87819, Exp 4/2021, 88244, Exp 6/2021, 88245, Exp 6/2021, 88532, Exp 06/2021 & 88533, Exp 7/2021.