Recall: D-0021-2023

Class II - Potentially Harmful

Class IIClassification

2022-10-05Initiated

CompletedStatus

Aurobindo Pharma USA Inc.Firm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.