85%Confidence
0Views
FDASource
2026-03-19Date
Summary
Temozolomide Capsules recall due to stability testing failures creates supply concerns for this critical brain cancer medication, potentially affecting patient treatment regimens. Rising Pharma's quality issues with a high-risk oncology product may trigger increased FDA scrutiny of their entire product portfolio.
Actionable: Assess alternative sources for Temozolomide and increase monitoring of Rising Pharma's other oncology products.
AI Confidence: 85%
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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