FDA recall D-0088-2022

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Distribution

Product was distributed to major distributors who may have further distributed the product nationwide.

Key facts

Status
Terminated
Initiation date
2021-10-12
Report date
2021-11-10
Termination date
2023-01-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0088-2022