Recall
FDAHealthOctober 31, 2024

Noven Pharmaceuticals Inc — Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, pac

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 31, 2024

USA nationwide.

What's affected?

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
Lot code
95598

Additional details

Lot # 95598, Exp 02/28/25

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 685 boxes.

View original FDA notice →

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