Status
Terminated
Drug Enforcement D-312-2013
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.
Classification
Class II
Report Date
May 8, 2013
Termination Date
December 28, 2016
Product Information
- Product description
- 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.
- Product quantity
- 335,910 patches
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Address
-
11960 Sw 144th St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-312-2013
- Event ID
- 64710
- Recall initiation date
- January 31, 2013
- Center classification date
- May 2, 2013
- Code info
- Lot #59824, Exp 04/13
- More code info
- —