Drug recall D-0295-2021
Product
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.
Lots and codes
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.
Recall details
- Recalling firm
- Noven Pharmaceuticals Inc, Miami, FL
- Quantity
- 786,900 patches
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 19, 2021
- Terminated
- July 5, 2024
Related products
- Daytrana – drug information
- NDC 68968-5554 Daytrana · Methylphenidate 20 mg/9h · Noven Therapeutics, LLC
- NDC 68968-5555 Daytrana · Methylphenidate 30 mg/9h · Noven Therapeutics, LLC
- NDC 68968-5553 Daytrana · Methylphenidate 15 mg/9h · Noven Therapeutics, LLC
- NDC 68968-5552 Daytrana · Methylphenidate 10 mg/9h · Noven Therapeutics, LLC