Another pharmaceutical company is recalling a blood pressure drug that may increase cancer risk if taken in large quantities.
The FDA on Wednesday recalled four batches of Lupine Pharmaceuticals Quinapril Tablets because the drug contained N-Nitroso-Quinapril with too many nitrosamine impurities.
The drug in question is marked as follows:
▪ Quinapril Tablets USP, 20mg | not much. G102929 | April 2023 expiry date
▪ Quinapril Tablets USP, 40mg | batch number G100533, G100534, G203071 | December 2022 and March 2024 expiration dates
Tablets are used in the treatment of hypertension and are packaged in bottles of 90. They were distributed to wholesalers, drugstore chains, mail-order pharmacies, and supermarkets nationwide. Lupine stopped marketing the drug in September and is informing businesses of the recall.
In October, Aurobindo Pharma recalled two lots of Quinapril due to the same nitrosamine impurity.
READ MORE HERE: More blood pressure drugs recalled for having too many impurities
What is Nitrosamine and N-Nitroso-Quinapril?
In the recall advice, the FDA says that nitrosamines are commonly found in water and foods (such as smoked and grilled meats, dairy products, and vegetables) to which everyone is exposed to some level.
However, impurities such as N-Nitroso-Quinapril can increase the risk of cancer if people are exposed above acceptable levels for a long time.
What to do if there is medicine?
No illness has been reported with 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, 9 am to 5 pm EST, Monday through Friday. For refunds, the drug must be returned to Inmar Rx Solutions, Inc.
Use the FDA’s MedWatch Adverse Event Reporting Program to report adverse reactions or quality issues:
▪ 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 notification form, then fill and mail the pre-addressed form to the address 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 the general mission. He graduated from the University of Florida and grew up in Miami. In and out of the office, he has theme parks, movies, and cars on his mind.
