Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc
Summary
The FDA issued a Class II for Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles D by Aurobindo Pharma USA Inc.. Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit..
Details
Source
Drug Recall
External ID
D-0021-2023
Action Date
2022-11-02
Status
Completed
Category
drug
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
Lot/Code Info: Lots QE2021005-A and QE2021010-A, exp 01/2023
Quantity Affected: 9504 bottles
Reason for Recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-05
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aurobindo Pharma USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc. have FDA actions?
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0021-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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