Enforcement Report - Week of June 20, 2012
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Product Detail
| 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. |
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| Recall Number | D-1372-2012 |
| Classification | Class II |
| Code Info | Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13 |
| Product Distributed Qty | 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. |
Event Detail
| Event Id | 61891 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Noven Pharmaceuticals, Inc. |
| City | Miami |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-07-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico. |
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