FDA-Drug2024-11-27Class II

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

Noven Pharmaceuticals Inc
Hazard

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Sold states
USA nationwide.
Affected count
685 boxes
Manufactured in
11960 Sw 144th St, N/A, Miami, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0055-2025

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