D-1172-2014 Class II Terminated
FDA drug recall D-1172-2014 was initiated by Noven Pharmaceuticals, Inc. on Feb 13, 2014 and is designated Class II. Reason for recall: Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior… The recall status is terminated (terminated Mar 19, 2019). Affected quantity: 117,600 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 26, 2014
- Initiation Date
- Feb 13, 2014
- Termination Date
- Mar 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117,600 patches
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.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: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Distribution Pattern
Nationwide.
Code Information
Lot #70132, Exp. 09/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1172-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026