D-0429-2017 Class II Terminated
FDA drug recall D-0429-2017 was initiated by Noven Pharmaceuticals, Inc. on Aug 22, 2016 and is designated Class II. Reason for recall: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. The recall status is terminated (terminated Mar 20, 2019). Affected quantity: 364,830 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 18, 2017
- Initiation Date
- Aug 22, 2016
- Termination Date
- Mar 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 364,830 patches
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Reason for Recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Distribution Pattern
Nationwide within the US
Code Information
Lot #: 79230, Exp. 02/2017; 77547, Exp.07/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0429-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026