Lupin Quinapril tablets recall: reason, affected lots, and other details explored

Lupin Pharmaceuticals Inc. has issued a nationwide Lupin Quinapril tablets recall over concerns about nitrosamine impurities.

The voluntary recall was followed by the discovery of elevated levels of nitrosamine impurities, N-Nitroso-Quinapril, in the tablets. While conducting voluntary lab tests on four lots of the tablets, the pharma company concluded that they contain impurities that could heighten the risk of cancer.

The Quinapril tablet USP under the Lupin Quinapril tablets recall is considered to be an angiotensin-converting enzyme (ACE) inhibitor, which is used to treat hypertension and lower blood pressure. Low blood pressure reduces the risk of fatal and nonfatal cardiovascular events like strokes, heart attacks, and myocardial infarctions.

---

All you need to know about Lupin Quinapril tablets recall

The recalled tablets under the Lupin Quinapril tablets recall were distributed to pharmacy stores and retailers nationwide between March 2021 and September 2022. Orders for the recalled product were also delivered through mail orders to addresses across the country. Available in labeled bottles, the Quinapril tablets are being pulled out of stores starting December 21.

The recall affects all Lupin Pharmaceuticals Inc.’s Quinapril tablets that are sold in 20 mg and 40 mg packs. The bottles carry expiration dates ranging from December 2022 to March 2024, and contain 90-tablets each. Customers can recognize the recalled Quinapril tablets by checking the bottles for the following details:

Product	Lot No	Expiry	NDC	UPC	Distribution Dates
Quinapril Tablets USP, 20mg	G102929	04/2023	68180-558-09 (90’s)	368180558095	03/15/2021
Quinapril Tablets USP, 40mg	G100533 G100534 G203071	12/2022 12/2022 03/2024	68180-554-09 (90’s)	368180554097	09/01/2022

Patients who are on a treatment which includes the use of the recalled Quinapril tablets are advised to continue taking the medication. Meanwhile, they should also get in touch with their pharmacist, physician, or medical provider and seek some advice regarding an alternative treatment.

Wholesalers and retailers who may still have the recalled products in stock are strictly advised to stop the distribution of the Quinapril Tablets.

People with doubts and queries related to the recalled products can contact the company, Inmar Rx Solutions, Inc. at (877) 538-8445, Monday to Friday, 09.00 am to 05.00 pm EST.

Recalled pack of 20 mg Quinapril tablets (Image via FDA)

---

What are the risks related to the Lupin Quinapril tablets recall

As Lupin Pharmaceuticals issued a nationwide Quinapril tablets recall, it is important to take a look at the risks related. For those who may not know, nitrosamines are naturally occurring organic compounds that humans are exposed to on an everyday basis.

These organic compounds naturally exist in food, water, meat, vegetables, and dairy products in low levels. Most medicines also contain nitrosamines that are produced naturally during the production process.

Though nitrosamines are naturally occurring compounds, they can be harmful when consumed in quantities above the accepted level, over a longer period of time. High exposure to nitrosamines can often increase the risk of cancer in patients. To ensure their safety, pharma companies must see that the nitrosamine content of any drug stays below the set Acceptable Daily Intake (ADI) level.

Recalled pack of 40 mg Quinapril tablets (Image via FDA)

If a drug fails to keep up with the proposed ADI levels, it is immediately recalled to ensure the safety of the patients. Similar to the Lupin Quinapril tablets recall, multiple drugs have been recalled this year because they surpassed the set nitrosamine ADI levels.