Status
Terminated
Drug Enforcement D-1373-2012
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 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.
- Product quantity
- 242,100 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-1373-2012
- Event ID
- 61891
- Recall initiation date
- July 5, 2011
- Center classification date
- June 14, 2012
- Code info
- Lot #: 43008, Exp 01/12; 48591, Exp 10/12
- More code info
- —