D-1086-2015 Class II Terminated
FDA drug recall D-1086-2015 was initiated by Noven Pharmaceuticals, Inc. on Jan 12, 2015 and is designated Class II. Reason for recall: Defective Delivery System: One lot exceeded the mechanical peel specification The recall status is terminated (terminated Mar 19, 2019). Affected quantity: 125,340 Patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 3, 2015
- Initiation Date
- Jan 12, 2015
- Termination Date
- Mar 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125,340 Patches
Product Description
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
Reason for Recall
Defective Delivery System: One lot exceeded the mechanical peel specification
Distribution Pattern
Nationwide
Code Information
Lot # 73346, Exp 03/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1086-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026