Recalls / Class II
Class IID-0293-2021
Product
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 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 68968-5552-3.
- Brand name
- Daytrana
- Generic name
- Methylphenidate
- Active ingredient
- Methylphenidate
- Route
- Transdermal
- NDCs
- 68968-5552, 68968-5553, 68968-5554, 68968-5555
- FDA application
- NDA021514
- Affected lot / code info
- Lots #: 87579, Exp 3/2021 & 88243, Exp 7/2021.
Why it was recalled
Defective Delivery System: Out of specification for mechanical peel.
Recalling firm
- Firm
- Noven Pharmaceuticals Inc
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, Miami, Florida 33186-6109
Distribution
- Quantity
- 473,280 patches
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-02-19
- FDA classified
- 2021-03-03
- Posted by FDA
- 2021-03-10
- Terminated
- 2024-07-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0293-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.