Recalls / Class II
Class IID-0021-2023
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
- Brand name
- Quinapril Hydrochloride/hydrochlorothiazide
- Generic name
- Quinapril Hydrochloride/hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Quinapril Hydrochloride
- Route
- Oral
- NDCs
- 65862-161, 65862-162, 65862-163
- FDA application
- ANDA078450
- Affected lot / code info
- Lots QE2021005-A and QE2021010-A, exp 01/2023
Why it was recalled
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 9504 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2022-10-05
- FDA classified
- 2022-10-26
- Posted by FDA
- 2022-11-02
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0021-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.