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
Reported: November 2, 2022 Initiated: October 5, 2022 #D-0021-2023
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.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 9504 bottles
- Distribution
- Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 9504 bottles.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 2, 2022. Severity: Moderate. Recall number: D-0021-2023.
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