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.
Reason
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Classification
Class II
Status
Ongoing
Lot
Lot #: 1TM0524003A, Exp. Date 09/2026.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Rising Pharma Holding, Inc. — Class II Recall | MedicineWatch US