Drug Enforcement D-0021-2023

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

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Status

Completed

Classification

Class II

Report Date

November 2, 2022

Termination Date

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Product Information

Product description
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
Product quantity
9504 bottles
Reason for recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc.
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0021-2023
Event ID
90949
Recall initiation date
October 5, 2022
Center classification date
October 26, 2022
Code info
Lots QE2021005-A and QE2021010-A, exp 01/2023
More code info
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