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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Temozolomide is a chemotherapy drug used in brain cancer treatment. The recall concerns impurities and degradation detected in stability testing.
Out-of-spec impurities can cause unknown toxicity or reduced drug efficacy. A stability failure indicates potential safety risk.
This recall is not described as part of a broader industry pattern.
Patients relying on Temozolomide may experience disruption in treatment. The recall affects 1,200 bottles nationwide and requires medical guidance.
NDC, lot number, and expiration appear on the bottle label. The recall URL provides official details.
Refunds or replacements, if offered, typically take 4-8 weeks after submission.
Keep packaging, recall notification, and all correspondence for records.
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.
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