Prescription Dextroamphetamine Patches Recalled for Defective Adhesive System
Noven Pharmaceuticals Inc is recalling 685 boxes of XELSTRYM (dextroamphetamine) transdermal patches nationwide due to a defect in the adhesive delivery system. The product does not meet manufacturing specifications.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription drug due to a manufacturing defect in the delivery system (adhesive). No illnesses or injuries have been reported, so the hazard is theoretical. Per the severity rubric, this qualifies as High (Score 3) for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Noven Pharmaceuticals Inc is recalling 685 boxes of XELSTRYM (dextroamphetamine) 13.5 mg/9-hour transdermal patches nationwide. The recall was issued by the U.S. Food and Drug Administration as a Class II recall.
The product does not meet predetermined manufacturing specifications for Coldflow adhesive, the component responsible for delivering the medication through the skin. This defect affects transdermal patches identified as Lot #95598, with an expiration date of February 28, 2025.
Consumers and healthcare providers who have XELSTRYM patches from the recalled lot should stop using them and contact their pharmacy or healthcare provider. Anyone with questions should contact Noven Pharmaceuticals Inc.
The recalled product
- Product
- XELSTRYM (DEXTROAMPHETAMINE)
- Brand
- XELSTRYM
- Manufacturer
- Noven Pharmaceuticals Inc
- Affected units
- 685
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 95598
- Exp 02/28/25
Distribution
Distributed nationwide across the United States.
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