Enforcement Report - Week of June 20, 2012
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Product Detail
| Product Description | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. |
|---|---|
| Recall Number | D-1374-2012 |
| Classification | Class II |
| Code Info | Lot #: 43783, Exp 01/12 |
| Product Distributed Qty | 244,320 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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