D-1248-2020 Class II Terminated
FDA drug recall D-1248-2020 was initiated by Noven Therapeutics, LLC on March 31, 2020 and is designated Class II. Reason for recall: Defective Delivery System: Out of specification for mechanical peel and shear. The recall status is terminated (terminated June 17, 2024). Affected quantity: 5,614 30-count boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2020
- Initiation Date
- March 31, 2020
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,614 30-count boxes
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Reason for Recall
Defective Delivery System: Out of specification for mechanical peel and shear.
Distribution Pattern
Distributed Nationwide in the US
Code Information
Lot: 86354 Exp. 08/2020