FDA recall D-1106-2018

Product

Valsartan Tablets USP, 320 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 59746-363-90

Reason for recall

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

Distribution

Product was distributed throughout the United States to wholesalers and retailers.

Key facts

Status

Terminated

Initiation date

2018-08-14

Report date

2018-08-29

Termination date

2020-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1106-2018