Drug product
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
D-0021-2023
Product summary
- Event
- Event 90949
- Status
- Completed
- Classification
- Class II
- Quantity
- 9504 bottles
- Official record key
drug-enforcement:D-0021-2023
Official wording
Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Code information: Lots QE2021005-A and QE2021010-A, exp 01/2023
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso-quinapril impurity
-
Manufacturing or process control
CGMP Deviations