Aurobindo Pharma USA Inc. recalls Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc
Recalled November 2, 2022 · FDA recall D-0021-2023 · Aurobindo Pharma USA
Hazard
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. · FDA Class II
Units
9504 bottles
Sold at
Nationwide
Description
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
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
Manufacturer(s)
Aurobindo Pharma USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →