REGULATORY INTELLIGENCE·Warning Letter
Noven Pharmaceuticals Initiates Nationwide Recall of Xelstrym Dextroamphetamine Transdermal Systems Over Adhesive Defect
Noven Pharmaceuticals Inc initiated a nationwide Class II recall of 685 boxes of Xelstrym (dextroamphetamine) transdermal systems due to a defective adhesive delivery system failing Coldflow specifications. This event impacts patient access to a critical CNS stimulant and necessitates immediate supply chain risk assessment for distributors and healthcare providers. Procurement teams must evaluate alternative sourcing strategies to mitigate potential supply disruptions for this essential medication.
90-Day Activity