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.

Recall Number: D-0001-2019

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20181010

Initiation Date: 20180921

Termination Date: 20190501

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

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.