D-0008-2016 Class II Terminated
FDA drug recall D-0008-2016 was initiated by Noven Pharmaceuticals, Inc. on Jul 27, 2015 and is designated Class II. Reason for recall: Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. The recall status is terminated (terminated Mar 20, 2019). Affected quantity: 125,250 Patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 14, 2015
- Initiation Date
- Jul 27, 2015
- Termination Date
- Mar 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125,250 Patches
Product Description
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Reason for Recall
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Distribution Pattern
US Nationwide
Code Information
Lot #: 75983, Expiry: 11/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0008-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026