FDA DrugClass IINotable

FDA Recall: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for:

Name: FDA Recall: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for:
Brand: Rising Pharma Holding, Inc.

Date: 2026-03-11

Brand: Rising Pharma Holding, Inc.

Category: Drug

FDA Class: Class II

Description

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Hazard

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Remedy

1200 bottles

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