Another drug company is recalling a blood pressure drug that may increase the risk of cancer if taken in large amounts.
Lupine Pharmaceuticals recalled four batches of quinapril tablets on Wednesday because the drug contains too much of the impurity nitrosamine N-nitroso-quinapril, the FDA announced.
The considered medication is labeled as follows:
▪ Quinapril Tablets USP, 20 mg | lot No. G102929 | expiration date until April 2023
▪ Quinapril Tablets USP, 40 mg | lot numbers G100533, G100534, G203071 | Expiry dates are December 2022 and March 2024
Tablets are used to treat hypertension and are packaged in bottles of 90 pieces. They were distributed across the country to wholesalers, chain pharmacies, mail-order pharmacies and supermarkets. Lupine stopped selling the drug in September and is notifying businesses of the recall.
In October, Aurobindo Pharma recalled two batches of quinapril due to the same nitrosamine impurity.
What is Nitrosamine and N-Nitroso-Quinapril?
In the recall advisory, the FDA says that nitrosamines are commonly found in water and foods — such as cured and grilled meats, dairy products and vegetables — that everyone is exposed to to some degree.
However, impurities such as N-Nitroso-Quinapril can increase the risk of cancer if people are exposed to them at higher than acceptable levels for a long period of time.
What if there is medicine?
There have been no reports of illness as a result of this recall, so consumers are not in immediate danger.
The FDA encourages anyone with questions about the recall to call Inmar Rx Solutions at 877-538-8445 between 9am and 5pm (EST), Monday through Friday. Medication must be returned to Inmar Rx Solutions, Inc. for reimbursement.
To report adverse reactions or quality concerns, use 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 www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or fax to 800-FDA-0178
▪ For more information on reporting to the FDA: https://www.fda.gov/safety/report-problem-fda