Recalls / Class II
Class IID-1655-2012
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 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 68968-5553-3.
- 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 #53823, Exp 08/12
Why it was recalled
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
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
- 231,270 patches
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-07-12
- FDA classified
- 2012-08-17
- Posted by FDA
- 2012-08-29
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1655-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.