82%Confidence
0Views
FDASource
2026-03-27Date
Summary
Rising Pharma's Temozolomide recall due to stability testing failures for impurities indicates potential quality issues with this important chemotherapy drug manufactured in Taiwan, which could affect cancer treatment protocols and patient safety. This may lead to increased FDA scrutiny of Rising's quality systems and could temporarily reduce availability of this generic brain cancer treatment.
Actionable: Oncology practices should verify their Temozolomide supplies and consider alternative sources until Rising demonstrates resolution of quality issues.
AI Confidence: 82%
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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