80%Confidence
0Views
FDASource
2026-03-24Date
Summary
Rising Pharma's Temozolomide recall due to stability testing failures indicates potential quality issues in oncology generics manufactured in Taiwan. This could affect patient treatment continuity for brain cancer and prompt increased FDA monitoring of their manufacturing facilities.
Actionable: Evaluate alternative sources for Temozolomide and monitor Rising Pharma's regulatory status for other oncology products.
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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