Enforcement Report - Week of July 18, 2012
-
Back to Previous Page
Product Detail
| 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. |
|---|---|
| Recall Number | D-1413-2012 |
| Classification | Class II |
| Code Info | Lot # 53995 |
| Product Distributed Qty | 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 |
Event Detail
| Event Id | 62002 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Noven Pharmaceuticals, Inc. |
| City | Miami |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-22 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide and Puerto Rico |
-
