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
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Classification
Class II
Status
Ongoing
Lot
Lot # 95598, Exp 02/28/25
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Noven Pharmaceuticals Inc — Class II Recall | MedicineWatch US