Product: Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Reason for recall: Failed dissolution specifications
Recall initiated: 20190219
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated