Class II
Ongoing
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
This recall is currently active, issued November 27, 2024. It was issued by Noven Pharmaceuticals, Inc..
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- October 31, 2024
- Posted
- November 27, 2024
- Recall Number
- D-0055-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 685 boxes
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Distribution
USA nationwide.
Lot / Code Info
Lot # 95598, Exp 02/28/25
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