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
Reason for recall: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Recall initiated: 20241031
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated