Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90

Recall Number: D-1104-2018

Firm: Jubilant Cadista Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180829

Initiation Date: 20180814

Termination Date: 20200108

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90