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
Reported: November 27, 2024 Initiated: October 31, 2024 #D-0055-2025
Product Description
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
Reason for Recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Details
- Recalling Firm
- Noven Pharmaceuticals Inc
- Units Affected
- 685 boxes
- Distribution
- USA nationwide.
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Noven Pharmaceuticals Inc. Units affected: 685 boxes.
Why was this product recalled? ▼
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2024. Severity: Moderate. Recall number: D-0055-2025.
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