Product: Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle,  Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Reason for recall: Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Recall initiated: 20140915
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated