Drug Enforcement D-0055-2025

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Status

Ongoing

Classification

Class II

Report Date

November 27, 2024

Termination Date

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Product Information

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
Product quantity
685 boxes
Reason for recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Noven Pharmaceuticals Inc
Address
11960 Sw 144th St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0055-2025
Event ID
95701
Recall initiation date
October 31, 2024
Center classification date
November 19, 2024
Code info
Lot # 95598, Exp 02/28/25
More code info
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