Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90

Recall Number: D-1293-2022

Firm: Jubilant Cadista Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220803

Initiation Date: 20220718

Termination Date: 20221122

Failed dissolution specifications.

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90