FDA Drug recall D-1171-2014
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch…
- FDA Drug
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch… by Noven Pharmaceuticals, citing defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the p….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1171-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-13 |
| Published | 2014-03-26 |
| 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 (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.
Reason
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| code_info | Lot #69618, Exp. 09/14 |
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-1171-2014%22
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