Over recent years, many medications have been recalled due to cancer-causing impurities. Certain types of blood pressure, diabetes, heartburn, and smoking cessation medications were included in these recalls. On December 21, 2022, Lupin Pharmaceuticals Inc. announced a voluntary recall of their product quinapril.
What is quinapril?
Quinapril is primarily used to treat high blood pressure but can also be used for other indications like heart failure and kidney protection in diabetes. It is part of a medication class called angiotensin-converting enzyme inhibitors (ACE inhibitors). It comes as both 20mg and 40mg tablets.
Why was it recalled?
The drug manufacturer, Lupin Pharmaceuticals, voluntarily recalled four different lots of quinapril tablets in December 2022. This recall was due to the finding of a nitrosamine substance, N-nitroso-quinapril. Nitrosamines are common in water and foods and most everyone is exposed to nitrosamines in their lifetime. However, it is when people are exposed to nitrosamines above acceptable levels over long periods of time that there may be an increased risk of cancer. Lupin Pharmaceuticals decided to recall the lot due to finding a level of nitrosamine above their established acceptable daily intake level. Nitrosamines can come from the manufacturing process, the chemical structure of the medicine, or storage or packaging conditions. These impurities are being identified more frequently now due to the availability of newer technology and testing methods, which make it easier to test for impurities.
What should you do if you’re taking quinapril?
There have not been any reports of illness related to this issue, but the manufacturer is taking proper precautions to protect consumers due to the findings described above. The recall has been established under the utmost caution to avoid something that is known to be potentially harmful. If you are taking quinapril, they advise you to continue taking the medication and contact your pharmacist, physician, or medical provider for advice and possible alternatives. If you believe you have experienced an adverse reaction, report it to the FDA (resources 2 & 3 below). The specific products being recalled are those listed in the table below from the FDA website.
| Product | Lot No | Expiry | NDC | Distribution Dates |
| Quinapril Tablets USP, 20mg | G102929 | 04/2023 | 68180-558-09 (90’s) | 03/15/2021 |
| Quinapril Tablets USP, 40mg | G100533 G100534 G203071 | 12/2022 12/2022 03/2024 | 68180-554-09 (90’s) | 09/01/2022 |
References:
References:
1) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-four-lots-quinapril-tablets-due#recall-announcement
2) www.fda.gov/medwatch/report.htm (online)
3) www.fda.gov/MedWatch/getforms.htm (mail or fax)
4) https://www.fda.gov/safety/report-problem-fda
Disclaimer: This blog is written for informational and educational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read or seen online.
