Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Recall Number: D-0876-2018
Firm: Jubilant Cadista Pharmaceuticals, Inc.
Classification: Class III
Status: Terminated
Report Date: 20180613
Initiation Date: 20180525
Termination Date: 20200108
Reason for Recall
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Product Description
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90