Status
Terminated
Drug Enforcement D-1653-2012
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.
Classification
Class II
Report Date
August 29, 2012
Termination Date
August 4, 2014
Product Information
- Product description
- Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 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 68968-5554-3.
- Product quantity
- 177,900 patches
- Reason for recall
- 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.
- 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, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1653-2012
- Event ID
- 62530
- Recall initiation date
- July 12, 2012
- Center classification date
- August 17, 2012
- Code info
- Lot # 55302, Exp 12/12
- More code info
- —