[pending] TEMOZOLOMIDE (TEMOZOLOMIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0384-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
The recalled product
- Product
- TEMOZOLOMIDE (TEMOZOLOMIDE)
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1TM0524003A
- Exp. Date 09/2026.
Distribution
Distributed nationwide across the United States.
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