Recall D-0055-2025

US Class II Ongoing · initiated 2024-10-31

Recalling firm

Noven Pharmaceuticals Inc, FL

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).

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