FDAFDA · Food and drugs·Recall number D-0021-2023
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
Published November 2, 2022 · Recall initiated: October 5, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Nationwide
- UPC
- 0365862161901
- Lot
- Lots QE2021005-A and QE2021010-A, exp 01/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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