Recalls / Class II
Class IID-1373-2012
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.
- Affected lot / code info
- Lot #: 43008, Exp 01/12; 48591, Exp 10/12
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.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, Miami, Florida 33186-6109
Distribution
- Quantity
- 242,100 patches
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2011-07-05
- FDA classified
- 2012-06-14
- Posted by FDA
- 2012-06-20
- Terminated
- 2013-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1373-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.