FDA-Drug2022-11-02Class II

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

Aurobindo Pharma USA Inc.
Hazard

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

Sold states
Nationwide
Affected count
9504 bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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

Official notice

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

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