Drug product
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
D-0055-2025
Product summary
- Event
- Event 95701
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 685 boxes
- Official record key
drug-enforcement:D-0055-2025
Official wording
Reason: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Code information: Lot # 95598, Exp 02/28/25
Distribution pattern: USA nationwide.
Derived failure modes
-
Unknown
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).