FDAFDA · Food and drugs·Recall number D-0055-2025
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
Published November 27, 2024 · Recall initiated: October 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- XELSTRYM
- Manufacturer
- Noven Pharmaceuticals Inc
- Distributor
- USA nationwide.
- Lot
- Lot # 95598, Exp 02/28/25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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