Product: 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.
Reason for recall: Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Recall initiated: 20181005
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated