D-1439-2016 Class II Terminated
FDA drug recall D-1439-2016 was initiated by Noven Pharmaceuticals, Inc. on Dec 21, 2015 and is designated Class II. Reason for recall: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner… The recall status is terminated (terminated Mar 19, 2019). Affected quantity: 2088 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2016
- Initiation Date
- Dec 21, 2015
- Termination Date
- Mar 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2088 boxes
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 z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Distribution Pattern
Nationwide
Code Information
Lot # 77140, Exp 05/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1439-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026