80%Confidence
0Views
FDASource
2026-03-18Date
Summary
Rising Pharma's temozolomide recall due to stability testing failures threatens supply of this critical glioblastoma treatment and indicates potential quality issues at their Taiwan manufacturing site. This could lead to increased market share for competing generic manufacturers while prompting FDA to increase scrutiny on oncology drug imports from Taiwan.
Actionable: Diversify temozolomide sourcing and increase testing frequency for oncology drugs from similar manufacturing regions.
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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