Recalls / Class II
Class IID-0008-2016
Product
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, 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 #: 75983, Expiry: 11/15
Why it was recalled
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Recalling firm
- Firm
- Noven Pharmaceuticals, Inc.
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 11960 SW 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 125,250 Patches
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2015-07-27
- FDA classified
- 2015-10-06
- Posted by FDA
- 2015-10-14
- Terminated
- 2019-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0008-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.