Status
Terminated
Drug Enforcement D-1413-2012
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Classification
Class II
Report Date
July 18, 2012
Termination Date
May 9, 2014
Product Information
- Product description
- Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
- Product quantity
- 185,160 patches
- Reason for recall
- Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- 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-1413-2012
- Event ID
- 62002
- Recall initiation date
- March 22, 2012
- Center classification date
- July 12, 2012
- Code info
- Lot # 53995
- More code info
- —