FDA recall D-0089-2022

Product

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) 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-0089-2022