FDA-Drug2022-08-03Class II

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

Failed Dissolution Specifications

Sold states
Nationwide within the United States
Affected count
28,560 bottles
Manufactured in
207 Kiley Dr, Salisbury, MD, United States
Products
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1294-2022

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