risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.

Recall Number: D-0725-2016

Firm: Zydus Pharmaceuticals USA Inc

Classification: Class III

Status: Terminated

Report Date: 20160302

Initiation Date: 20160114

Termination Date: 20201218

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.