Aurobindo Pharma USA, Inc. Issues a Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg Due to the Presence of Detection of N-Nitroso Quinapril Impurity

Quinapril and Hydrochlorothiazide Tablets

Aurobindo Pharma USA, Inc. is voluntarily recalling two (2) lots of Quinapril Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg to the patient/consumer level. These lots are being recalled because they have been found to contain trace amounts of an unexpected impurity called N-nitroso quinapril, during a routine stability test.

The presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril is noted to exceed the proposed interim limit.

Aurobindo Pharma USA, Inc distributed the affected batches QE2021005-A and QE2021010-A in May 2021 to its consumers nationwide.

 

NDC No. Product Name, strength, and pack Lot number Expiry
65862-162-90 Quinapril and Hydrochlorothiazide

Tablets USP, 20mg / 12.5mg,

90’s HDPE bottle

QE2021005-A 01/2023
QE2021010-A

Risk Statement

This impurity, which is a by-product of the manufacturing process, has been found to be carcinogenic (cancer-causing) in animal studies. Nitrosamines are commonly found in food and water including animal-based products and vegetables. Everyone is exposed to certain levels of Nitrosamines in their daily lives.

Long-term exposure to above-acceptable levels of Nitrosamines can increase the risk of cancer.

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

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, are used as fixed combination tablets for the treatment of hypertension, to lower blood pressure. The tablets combine angiotensin-converting enzyme (ACE) inhibitor, hydrochlorothiazide, quinapril hydrochloride, and a thiazide diuretic.

Got a Legal Issue? Let Us Help You Find An Attorney Near You

Patients talk to their healthcare providers to inquire whether they should continue using their prescribed medications or consider alternatives before returning the affected products.

You can identify Quinapril and Hydrochlorothiazide Tablets USP 20 mg / 12.5 mg with their pink-colored round-shaped, biconvex, film-coated tablets. They are debossed with ‘D’ on the scored side and ‘19’on the other side and supplied in 90’s HDPE bottles.

Actions Taken

Qualanex is notifying distributors and customers on behalf of Aurobindo Pharma USA, Inc. through letters and in writing. The distributors should immediately stop the distribution of the affected lots and customers who may have the product in their inventory should quarantine them until they are returned.

Aurobindo Pharma USA, Inc. is arranging the return of the affected products to Qualanex and will give the instructions through the recall letter.

Any medical questions or reports of advanced reactions should be reported to Aurobindo Pharma USA, Inc. at

Customers that have experienced problems related to the use of this product should contact their physicians and healthcare providers immediately.

General questions regarding the recall should be directed to Qualanex at 1-888-504- 2014 (live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Online: www.fda.gov/medwatch/report
  • Regular Mail: Use postage-paid, pre-addressed Form 3500 available at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Legal Giant is not a law firm and does not offer legal services.  We are a lawyer network platform that provides you access to hundreds of highly skilled attorneys in your area.  Our primary objective is to help you find a specialist lawyer for your case as fast as possible. We focus on practice area expertise and jurisdiction to offer you the best service possible.  Any information provided on this site is not legal advice, does not constitute a lawyer referral service, and no attorney-client or confidential relationship is or will be formed by the use of our site.

Leave a Comment

Scroll to Top

Legal Giant’s mission is to connect you with highly experienced attorneys when you need legal help, just like it’s our own family.Our team of experienced writers and legal editors is fully committed to providing high-quality content and accurate information.

Our content is fact checked and approved by our team of editors and practicing attorneys. Should you find an error within any of our website content, please feel free to contact us and let us know.

Tell us about your case to get started.