80%Confidence
0Views
FDASource
2026-03-30Date
Summary
Rising Pharma's Temozolomide recall due to stability testing failures suggests potential quality issues with their oncology product line manufactured in Taiwan. This could impact their ability to supply this important cancer medication and may affect their ANDA pipeline.
Actionable: Assess potential market share opportunities for competitors in the temozolomide market.
AI Confidence: 80%
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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