Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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