Recalls / Class II
Class IID-1044-2020
Product
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3
- 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
- Lo#t: 86081, Exp 04/2020; 86196, Exp 06/2020
Why it was recalled
Defective Delivery System: Out of specification for mechanical peel and shear.
Recalling firm
- Firm
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, Miami, Florida 33186-6109
Distribution
- Quantity
- 11093 boxes
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-03-02
- FDA classified
- 2020-03-19
- Posted by FDA
- 2020-03-25
- Terminated
- 2023-05-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1044-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.