D-0296-2021 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
- 934,140 patches
Product Description
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 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 68968-5555-3.
Reason for Recall
Defective Delivery System: Out of specification for mechanical peel.
Distribution Pattern
Nationwide in the USA
Code Information
Lots #: 87377, Exp 3/2021, 87572, Exp 3/2021, 87581, Exp 4/2021, 87820, Exp 5/2021, 88246, Exp 6/2021, 88535, Exp 7/2021, 88536, Exp 8/2021, 88537, Exp 8/2021 & 88939, Exp 8/2021.