D-0384-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- March 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 bottles
Product Description
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 for Recall
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 1TM0524003A, Exp. Date 09/2026.