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.
Classification
Class II
Status
Completed
Lot
Lots QE2021005-A and QE2021010-A, exp 01/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Aurobindo Pharma USA Inc. — Class II Recall | MedicineWatch US