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

Recall Number: D-0021-2023

Firm: Aurobindo Pharma USA Inc.

Classification: Class II

Status: Completed

Report Date: 20221102

Initiation Date: 20221005

Termination Date:

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

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