FDA-Drug2018-08-29Class III

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

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

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

Sold states
Product was distributed throughout the United States to wholesalers and retailers.
Affected count
9,552 bottles
Manufactured in
207 Kiley Dr, Salisbury, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1104-2018

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