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.
- Recalling firm
- Rising Pharma Holding, Inc.
- 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.
- Reason
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-03
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/40020606-166b-46ef-a6b3-562cf2544887