Rising Pharma Holding, Inc.: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-03-03
- Code info
- Lot #: 1TM0524003A, Exp. Date 09/2026.
- Product quantity
- 1200 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- East Brunswick
- State
- NJ
- Country
- United States
- Event id
- 98523
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