Valsartan Tablets USP recalled over undeclared excipient

Recall date

August 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, M…

Recall number

D-1104-2018

FDA classification

Class III

Brand / firm

Jubilant Cadista Pharmaceuticals, Inc.

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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