Recalling firm
Noven Pharmaceuticals Inc
Product type
Drug
Status
Ongoing
Report date
2024-11-27
Distribution
USA nationwide.
Firm state
FL
Product quantity
685 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
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
Code / lot info
Lot # 95598, Exp 02/28/25
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.