D-0428-2017 Class II Terminated
FDA drug recall D-0428-2017 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: 1,068,600 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
- 1,068,600 patches
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3
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 #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0428-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026