FDA recall D-0021-2023

Product

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90

Reason for recall

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Distribution

Nationwide

Key facts

Status

Completed

Initiation date

2022-10-05

Report date

2022-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0021-2023