D-0627-2018 Class II Terminated
FDA drug recall D-0627-2018 was initiated by Noven Pharmaceuticals, Inc. on Apr 9, 2018 and is designated Class II. Reason for recall: Defective Delivery System: Out of specification for adhesive transfer. The recall status is terminated (terminated Jan 24, 2020). Affected quantity: 9016 boxes of 30 patch each.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 25, 2018
- Initiation Date
- Apr 9, 2018
- Termination Date
- Jan 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9016 boxes of 30 patch each
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Reason for Recall
Defective Delivery System: Out of specification for adhesive transfer.
Distribution Pattern
Nationwide.
Code Information
Lot #: 82237 Exp. May 31, 2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0627-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026