D-1043-2020 Class II Terminated
FDA drug recall D-1043-2020 was initiated by Noven Therapeutics, LLC on March 2, 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 May 18, 2023). Affected quantity: 13761 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- March 2, 2020
- Termination Date
- May 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13761 boxes
Product Description
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3
Reason for Recall
Defective Delivery System: Out of specification for mechanical peel and shear.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot#: 85942, Exp 03/2020; 86281, Exp 06/2020