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Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Mark

Recalled June 13, 2018 · FDA recall D-0876-2018 · Jubilant Cadista Pharmaceuticals

Hazard
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone). · FDA Class III
Units
2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Sold at
IN, MI, MS, NC, NJ, NY and OH

Description

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Product
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
Manufacturer(s)
Jubilant Cadista Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Mark | RecallWatchUSA