Another pharmaceutical company is recalling a blood pressure drug that can increase the risk of cancer if taken in large amounts.
On Wednesday, Lupine Pharmaceuticals recalled four lots of Quinapril tablets because the drug was high in the nitrosamine impurity N-Nitroso-Quinapril, the FDA announced.
The drug in question is listed as:
▪ Quinapril Tablets USP, 20mg | batch number. G102929 | Expiry date of April 2023
▪ Quinapril Tablets USP, 40mg | lot no. G100533, G100534, G203071 | expiration dates December 2022 and March 2024
Tablets are used for the treatment of hypertension and are packed in a glass container of 90 pieces. They are distributed nationwide to wholesalers, drugstore chains, mail order pharmacies and supermarkets. Lupine stopped selling the drug in September and is notifying companies of the recall.
In October, Aurobindo Pharma recalled two lots of Quinapril due to the same nitrosamine impurity.
READ MORE: More blood pressure drugs recalled for being too dirty
What is Nitrosamine and N-Nitroso-Quinapril?
The FDA said in the recall advisory that nitrosamines are commonly found in water and foods — such as cured and fried meats, dairy products and vegetables — to which everyone is exposed at some level.
However, impurities such as N-Nitroso-Quinapril may increase the risk of cancer if humans are exposed above acceptable levels over long periods of time.
What to do if there is medicine?
No illnesses have been reported as a result of 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). Medication must be returned to Inmar Rx Solutions, Inc. for reimbursement.
Use the FDA’s MedWatch Adverse Event Reporting Program to report adverse reactions or quality problems:
▪ 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 report form, then complete and return the pre-addressed form or fax it to 800-FDA-0178.
▪ For more information about reporting to the FDA: https://www.fda.gov/safety/report-problem-fda
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Miami Herald Real Time reporter Devon Cetoute covers breaking news, Florida’s coronavirus pandemic and general assignments. He is a graduate of the University of Florida and grew up in Miami. In and out of the office, theme parks, movies and cars come to mind.
