Recalls / Class II
Class IID-1086-2015
Product
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
- 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 # 73346, Exp 03/2015
Why it was recalled
Defective Delivery System: One lot exceeded the mechanical peel specification
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
- 125,340 Patches
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-01-12
- FDA classified
- 2015-05-28
- Posted by FDA
- 2015-06-03
- Terminated
- 2019-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1086-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.