Xelstrym Patch, Extended Release
FDA Recall NDC 68968-0205
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Xelstrym (NDC 68968-0205). A significant event, classified as Class II, was initiated on Oct 31, 2024 by Noven Therapeutics, Llc. The reported reason for this action was: "Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive)."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Oct 31, 2024
Nov 27, 2024
685 boxes
Recall Profile & Regulatory Data
Event ID
95701
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
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
Batch or Lot Expiration Information
Lot# 95598, Exp 02/28/25
Affected Packages Involved in this Recall
68968-0205-1Product
68968-0205-3Product
68968-0210-1Product
68968-0210-3Product
68968-0215-1Product
68968-0215-3Product
68968-0220-1Product
68968-0220-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
