October 2024 FDA Recall Xelstrym by Noven Pharmaceuticals Inc
D-0055-2025 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Noven Pharmaceuticals Inc on October 31, 2024 for the product Xelstrym. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0055-2025
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
10-31-2024
11-27-2024
685 boxes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 95598, Exp 02/28/25
