Quinapril and Hydrochlorothiazide Tablets recall: Impurity Out of Spec
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
Why was Quinapril and Hydrochlorothiazide Tablets recalled?
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots QE2021005-A and QE2021010-A, exp 01/2023
- 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
- Recalling firm
- Aurobindo Pharma USA Inc.
- Quantity
- 9504 bottles
- Distribution
- Nationwide
- Recall date
- November 2, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)