Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
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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