Recalls / Class II
Class IID-0429-2017
Product
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
- 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 #: 79230, Exp. 02/2017; 77547, Exp.07/2016
Why it was recalled
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
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
- 364,830 patches
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2016-08-22
- FDA classified
- 2017-01-10
- Posted by FDA
- 2017-01-18
- Terminated
- 2019-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0429-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.