D-0055-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2024
- Initiation Date
- October 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 685 boxes
Product Description
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3
Reason for Recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Distribution Pattern
USA nationwide.
Code Information
Lot # 95598, Exp 02/28/25