Lupin Pharmaceuticals is issuing a voluntary nationwide recall of four lots of Quinapril tablets due to the potential presence of an N-Nitroso-Quinapril impurity.
N-Nitroso-Quinapril is a nitrosamine impurity identified as a probable human carcinogen based on laboratory testing.
The recall was initiated after recent testing confirmed that the level of N-Nitroso-Quinapril impurity in the affected lots exceeded the USP Acceptable Daily Intake Limit. To date, Lupin has not received any reports of adverse events.
Nitrosamines are commonly found in water and foods such as dairy products, vegetables, and processed meats. This means that everyone is exposed to some levels of nitrosamines in their daily lives.
Although the risk associated with consuming nitrosamine impurities is low, long-term exposure above recommended levels may increase the risk of cancer.
Lupin stopped the marketing of Quinapril tablets in September 2022.
Indications
Quinapril tablet USP is indicated for the treatment of hypertension and for the treatment of congestive heart failure in patients who are stable on diuretics and ACE inhibitor therapy.
The angiotensin-converting enzyme (ACE) inhibitor is also indicated to lower blood pressure to reduce fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions.
Quinapril Tablets USP 20mg and 40mg were packed in 90-count bottles and distributed to wholesalers, distributors, and retailers nationwide in the U.S. The information about the affected products is indicated in the table below:
| Product | Lot No | Expiry | NDC | UPC | Distribution Dates |
| Quinapril Tablets USP, 20mg | G102929 | 04/2023 | 68180-558-09
(90’s) |
368180558095 | 03/15/2021 – 09/01/2022 |
| Quinapril Tablets USP, 40mg | G100533
G100534 G203071 |
12/2022
12/2022 03/2024 |
68180-554-09
(90’s) |
368180554097 |
Actions by Lupin
Lupin Pharmaceuticals Inc. is alerting wholesalers, distributors, and retailers to discontinue further distribution of these immediately recalled lots and return them to the point of purchase.
Patients who have purchased products affected by this recall should contact their pharmacist or healthcare providers for an alternative treatment. They should discontinue the use and discard or return the affected products to the point of purchase.
Customers, distributors, wholesalers, and retailers with questions regarding this recall can contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday – Friday, 09:00 am to 05:00 pm EST.
Any adverse reactions or quality issues can be reported to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Lupin is committed to the highest standards of quality assurance and patient safety for all our products and continues to monitor the situation closely. Lupin regrets any inconvenience caused by this recall.
