FDA-Drug2022-08-03Class II

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

Failed dissolution specifications.

Sold states
Nationwide within the United States
Affected count
9,600 bottles
Manufactured in
207 Kiley Dr, Salisbury, MD, United States
Products
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1293-2022

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