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

Code information: Lot #: 1TM0524003A, Exp. Date 09/2026.

Distribution pattern: Nationwide within the U.S