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.
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
- 1-866-850-2876 (Option 2), 24 hours per day, 7 days per week; or
- [email protected]
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.
