80%Confidence
0Views
FDASource
2026-03-22Date
Summary
Rising Pharma's recall of Temozolomide Capsules due to stability testing failures indicates potential quality issues with oncology products manufactured in Taiwan. This could disrupt supply for this important brain cancer treatment and trigger increased FDA scrutiny of Rising's manufacturing operations.
Actionable: Monitor Temozolomide supply chain and consider qualifying alternative manufacturers for this critical oncology product.
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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