🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: October 5, 2022 Aurobindo Pharma USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots QE2021005-A and QE2021010-A, exp 01/2023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aurobindo Pharma USA Inc.
Reason for Recall:
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full 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

Product Codes/Lot Numbers:

Lots QE2021005-A and QE2021010-A, exp 01/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0021-2023

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