Recalls / Class II
Class IID-1172-2017
Product
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3
- 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: 80426 Exp. 10/17
Why it was recalled
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Recalling firm
- Firm
- Noven Pharmaceuticals, Inc.
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 SW 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 234,960 patches
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2017-08-30
- FDA classified
- 2017-09-18
- Posted by FDA
- 2017-09-27
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1172-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.