Recalls / Class II
Class IID-312-2013
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, 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 #59824, Exp 04/13
Why it was recalled
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
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
- 335,910 patches
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2013-01-31
- FDA classified
- 2013-05-02
- Posted by FDA
- 2013-05-08
- Terminated
- 2016-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-312-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.