FDA Drug recall D-1169-2017
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven…
- FDA Drug
- Class II
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class II recall of Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven… by Noven Pharmaceuticals, citing defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1169-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-30 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3
Reason
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| code_info | Lot: 80433 Exp. 08/17 |
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-1169-2017%22
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