FDA recall D-1293-2022

Product

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

Reason for recall

Failed dissolution specifications.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-07-18

Report date

2022-08-03

Termination date

2022-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

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