FDA-Drug2026-03-11Class II
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.
Rising Pharma Holding, Inc.
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Sold states
Nationwide within the U.S
Affected count
1200 bottles
Manufactured in
2 Tower Center Blvd Ste 1401, N/A, East Brunswick, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2026Original summary
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. Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing Lot #: 1TM0524003A, Exp. Date 09/2026. Distribution: Nationwide within the U.S Affected quantity: 1200 bottles
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