Product: Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-5416-01  Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Reason for recall: Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Recall initiated: 20180921
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated