Noven Pharmaceuticals Inc: Drug Recall
Recall #D-0055-2025 · 10/31/2024
Class II: Risk
Recall Details
- Recall Number
- D-0055-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Noven Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 10/31/2024
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 685 boxes
Reason for Recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
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
Distribution Pattern
USA nationwide.
Other Recalls by Noven Pharmaceuticals Inc
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 11/16/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.