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FDARecalled Mar 11, 2026 · #D-0384-2026

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.

Hazard

Class II — temporary health risk

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Description

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing Classification: Class II Distribution: Nationwide within the U.S

Product details

Product
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Type
Drugs
Manufacturer
Rising Pharma Holding, Inc.
Model numbers
1TM0524003A
UPCs