Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal p
Summary
The FDA issued a Class II for Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hou by Noven Pharmaceuticals Inc. Reason: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive)..
Details
Source
Drug Recall
External ID
D-0055-2025
Action Date
2024-11-27
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # 95598, Exp 02/28/25
Quantity Affected: 685 boxes
Reason for Recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-31
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 166 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Noven Pharmaceuticals Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Noven Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Noven Pharmaceuticals Inc have FDA actions?
Noven Pharmaceuticals Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0055-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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