83%Confidence
0Views
FDASource
2026-03-31Date
Summary
Rising Pharma's Temozolomide recall due to stability testing failures indicates potential degradation issues that could affect this critical oncology medication's efficacy. The Taiwan manufacturing origin raises questions about international quality control standards and may prompt increased FDA scrutiny of imported oncology drugs.
Actionable: Monitor Temozolomide supply availability and consider qualifying alternative manufacturers for this essential chemotherapy drug.
AI Confidence: 83%
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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