Another pharmaceutical company is recalling a blood pressure medication that can increase the risk of cancer if taken in large amounts.
On Wednesday, Lupine Pharmaceuticals recalled four batches of Quinapril tablets because the medicine has too much of the nitrosamine impurity N-Nitroso-Quinapril, the FDA announced.
The medicine in question is labeled as:
▪ Quinapril Tablets USP, 20mg | Lot No. G102929 | expiry date April 2023
▪ Quinapril Tablets USP, 40mg | Lot No. G1[ads1]00533, G100534, G203071 | the expiry dates of December 2022 and March 2024
The tablets are used to treat hypertension and are packed in 90-count bottles. They were distributed across the country to wholesalers, pharmacy 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 due to the same nitrosamine impurity.
READ MORE HERE: Several blood pressure medicines have been recalled for having too many impurities
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 meats and grilled meats, dairy products and vegetables — that everyone is exposed to at one level or another.
However, impurities such as N-Nitroso-Quinapril can increase the risk of cancer if people are exposed to it above acceptable levels over a long period of time.
What should you do if you have the medicine?
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, from 9:00 am to 5:00 pm (EST) Monday through Friday. For reimbursement, the medication must be returned to Inmar Rx Solutions, Inc.
To report side effects or quality concerns, 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 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 preaddressed form, or submit by fax to 800-FDA-0178
▪ For more information on reporting to the FDA: https://www.fda.gov/safety/report-problem-fda