Class II
Completed
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
- Company
- Aurobindo Pharma Usa Inc.
- Recall Initiated
- October 5, 2022
- Posted
- November 2, 2022
- Recall Number
- D-0021-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9504 bottles
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Distribution
Nationwide
Lot / Code Info
Lots QE2021005-A and QE2021010-A, exp 01/2023
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