Status
Terminated
Drug Enforcement D-1372-2012
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
June 20, 2012
Termination Date
May 23, 2013
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, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
- Product quantity
- 357,510 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
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1372-2012
- Event ID
- 61891
- Recall initiation date
- July 5, 2011
- Center classification date
- June 14, 2012
- Code info
- Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
- More code info
- —