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Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individual...

FDA Recall #D-0055-2025 — Class II — October 31, 2024

Recall #D-0055-2025 Date: October 31, 2024 Classification: Class II Status: Ongoing

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).

Recalling Firm

Noven Pharmaceuticals Inc — Miami, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

685 boxes

Distribution

USA nationwide.

Code Information

Lot # 95598, Exp 02/28/25

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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