Blood pressure drug recall due to cancer risk

Another pharmaceutical company is recalling a blood pressure drug that could increase the risk of cancer if taken in large amounts.

On Wednesday, Lupine Pharmaceuticals recalled four lots of Quinapril tablets because the drug contains too much of the nitrosamine impurity N-nitroso-quinapril, the FDA said.

The drug in question is marked as:

Quinapril Tablets USP, 20 mg | Lot number G102929 | Expiry date April 2023

Quinapril Tablets USP, 40 mg | Lot numbers G100533, G100534, G203071 | Expiry dates December 2022 and March 2024

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The FDA announced that Lupine Pharmaceuticals has recalled four lots of Quinapril tablets, a high blood pressure drug, due to high levels of nitrosamine impurities. FDA
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The FDA announced that Lupine Pharmaceuticals has recalled four lots of Quinapril tablets, a high blood pressure drug, due to high levels of nitrosamine impurities. FDA

The tablets are used to treat high blood pressure and are packaged in bottles of 90 pieces. They were sold nationwide to wholesalers, drugstore chains, mail-order pharmacies and supermarkets. Lupine stopped marketing the drug in September and is notifying companies of the recall.

In October, Aurobindo Pharma recalled two batches of quinapril for the same nitrosamine impurity.

READ MORE HERE: More blood pressure drugs have been recalled because they contained too many impurities

What is Nitrosamine and N-Nitroso-Quinapril?

In its recall advisory, the FDA says nitrosamines are commonly found in water and foods — like cured and grilled meats, dairy products, and vegetables — to which everyone is exposed to some degree.

However, impurities like N-nitroso-quinapril can increase the risk of cancer when people are exposed to it above acceptable levels for a long time.

What to do if you have the drug

There have been no reports of illness from this recall, so consumers are not in immediate danger.

The FDA advises anyone with questions about the recall to call Inmar Rx Solutions at 877-538-8445 Monday through Friday, 9 a.m. to 5 p.m. EST. Drug must be returned to Inmar Rx Solutions, Inc. for refunds.

To report adverse events or quality issues, use the FDA’s MedWatch Adverse Event Reporting Program:

Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular mail or fax: Download the form at www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a report form, then complete and mail it to the address the pre-addressed form or fax it to 800-FDA-0178

For more information on reporting to the FDA: https://www.fda.gov/safety/report-problem-fda

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Miami Herald Real Time reporter Devoun Cetoute covers breaking news, Florida’s coronavirus pandemic and general duties. He graduated from the University of Florida and grew up in Miami. Theme parks, movies and cars keep him busy in and out of the office.

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