FDA Drug recall D-1413-2012
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packag…
- FDA Drug
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packag… by Noven Pharmaceuticals, citing miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1413-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-22 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| ndc | 68968-5554-01 |
| code_info | Lot # 53995 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1413-2012%22
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