Drug recall notice for quinapril and hydrochlorothiazide tablets

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of 2 lots of quinapril and hydrochlorothiazide 20 mg/12.5 mg tablets on Oct. 24, 2022.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

The drug manufacturer, Aurobindo Pharma USA Inc., is voluntarily recalling these products due to the presence of a nitrosamine drug substance-related impurity, N-nitroso-quinapril, above the proposed interim limit.

N-nitroso-quinapril impurity is classified as a probable human carcinogen found in trace amounts in water and some foods; however, the amounts identified in the drug products are at unacceptable levels.

To date, Aurobindo Pharma USA Inc. has not received any reports of adverse events related to this recall.

Medications included in this recall

Product name NDC number Lot number Expiration date Quinapril and hydrochlorothiazide 20 mg/12.5 mg tablets, 90-count bottle 65862-0162-90 QE2021005-A 01/2023 Quinapril and hydrochlorothiazide 20 mg/12.5 mg tablets, 90-count bottle 65862-0162-90 QE2021010-A 01/2023

Recommendations

Other manufacturers and other lot numbers are unaffected and readily available.

To access Humana’s formulary drug list search, go to: Humana.com/Provider/Pharmacy-Resources/Tools/Humana-Drug-Lists.

Information for providers:1

  • We have sent a letter to your Humana-covered patients who have had a claim for quinapril and hydrochlorothiazide 20 mg/12.5 mg tablets and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.

     

  • Healthcare providers with questions can contact:
    • Aurobindo Pharma USA Inc. at 866-850-2876 (option 2), 24 hours a day, 7 days a week.
  • Patients may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form.
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity,” U.S. Food and Drug Administration, last accessed Oct. 31, 2022, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and.