Another drug 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 batches of Quinapril tablets because the drug contains 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 | expiration date April 2023
▪ Quinapril Tablets USP, 40 mg | lot no. G100533, G100534, G203071 | expiration dates in December 2022 and March 2024
The tablets are used for the treatment of hypertension and are packed in bottles of 90 pieces. They are distributed nationwide to wholesalers, drugstore chains, pharmacies and supermarkets. Lupine stopped selling 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: Multiple blood pressure drugs recalled due to excessive impurities
What is nitrosamine and N-nitroso-quinapril?
In its recall advisory, the FDA says nitrosamines are commonly found in water and foods — such as cured and grilled meats, dairy products and vegetables — that everyone is exposed to at some level.
However, impurities, such as N-nitroso-quinapril, can increase the risk of cancer if people are exposed above acceptable levels for long periods of time.
What to do if you have medication?
There have been no reports of illness since this recall, so consumers are not in immediate danger.
FDA advises anyone with questions about the recall to call Inmar Rk Solutions at 877-538-8445, 9 a.m. to 5 p.m. (EST), Monday through Friday. For reimbursement, the drug must be returned to Inmar Rk Solutions, Inc.
To report adverse reactions or quality problems, use the FDA’s MedWatch Adverse Event Reporting Program:
▪ Complete and submit the report online: www.fda.gov/medvatch/report.htm
▪ Regular mail or fax: Download the form at www.fda.gov/MedVatch/getforms.htm or call 800-332-1088 to request an application form, then complete and return to the address on the pre-addressed form or fax it to 800-FDA-0178
▪ For more information on reporting to the FDA: https://www.fda.gov/safeti/report-problem-fda