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
- Brand
- XELSTRYM
- 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.
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