Rising Pharmaceuticals recalls 1,200 Temozolomide 5 mg capsules nationwide after a stability test found out-of-spec impurities. The drug is Rx-only, with NDC 16571-816-51 and lot 1TM0524003A. Stop using immediately and contact a healthcare provider for guidance.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Consumers and healthcare providers should stop using this product immediately. Contact Rising Pharma Holding, Inc. or your healthcare provider for guidance. Notification method: Letter
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NDC: 16571-816-51. Lot: 1TM0524003A. Expiration: 09/2026. Quantity: 1,200 bottles. Distribution: Nationwide in the U.S. Manufactured for: Rising Pharmaceuticals, Allendale, NJ 07401. Country of origin: Taiwan.
Out-of-spec impurities/degradation detected during 9th-month long-term stability testing. The defect is related to chemical stability of Temozolomide 5 mg capsules.
1. Stop using the product. 2. Contact Rising Pharmaceuticals or your healthcare provider for guidance. 3. Follow the notification method in the recall notice. 4. Monitor for updates from the FDA enforcement page.
Recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0384-2026. Manufacturer: Rising Pharmaceuticals. Phone/Hours: Not provided in the recall notice. If you need guidance, consult your pharmacist or physician.
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