D-0021-2023 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- November 2, 2022
- Initiation Date
- October 5, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9504 bottles
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
Reason for Recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Distribution Pattern
Nationwide
Code Information
Lots QE2021005-A and QE2021010-A, exp 01/2023