83%Confidence
0Views
FDASource
2026-04-01Date
Summary
Rising Pharma's Temozolomide stability failure indicates potential degradation issues in this critical oncology medication, which could compromise treatment efficacy. This may signal broader quality control problems at the Taiwan manufacturing facility.
Actionable: Review stability data for all products from the affected manufacturing site and consider additional testing for temozolomide inventory.
AI Confidence: 83%
Data Points
firmRising Pharma Holding, Inc.
classificationClass II
statusOngoing
distributionNationwide within the U.S
productProduct label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401
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