Recalls / Class II
Class IID-0889-2022
Product
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, 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
- Lot: 90764 Exp. 08/2022
Why it was recalled
Defective Delivery System: customer complaints exceeded respective action limits.
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
- 274, 110 patches
- Distribution pattern
- Nationwide to the U.S. Market
Timeline
- Recall initiated
- 2022-05-06
- FDA classified
- 2022-05-20
- Posted by FDA
- 2022-06-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0889-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.