Drug recall D-0296-2021
Product
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.
Lots and codes
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.
Recall details
- Recalling firm
- Noven Pharmaceuticals Inc, Miami, FL
- Quantity
- 934,140 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