REGULATORY INTELLIGENCE·Recall
Viatris Initiates US Nationwide Class II Recall for Xanax XR (Alprazolam) Due to Dissolution Failure
Viatris, Inc. has initiated a US nationwide Class II recall for specific lots of Xanax XR (alprazolam) extended-release tablets due to failed dissolution specifications. This voluntary action, impacting 3 mg tablets, signals potential inconsistencies in drug release, posing risks of sub-optimal therapeutic effects for patients. Procurement and regulatory teams must assess supply chain continuity and monitor Viatris's remediation efforts to mitigate potential market disruptions for this critical benzodiazepine.
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