Pfizer recalls Accupril blood pressure tablets due to a nitrosamine impurity
Summary
You can continue to take your medication as prescribed by your health care provider and you do not need to return their medication to your pharmacy, but you should contact your health care provider to discuss other treatment options. Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk.
Affected products
| Product | DIN | Lot | Expiry | Date added |
|---|---|---|---|---|
| Accupril 10mg | 01947672 | DY3042 | 2023-03-31 | 2022-04-21 |
| Accupril 10mg | 01947672 | CK5285 | 2022-05-31 | 2022-04-21 |
| Accupril 20mg | 01947680 | DT9592 | 2023-03-31 | 2022-04-21 |
| Accupril 20mg | 01947680 | CK6258 | 2022-05-31 | 2022-04-21 |
| Accupril 20mg | 01947680 | CK6259 | 2022-05-31 | 2022-04-21 |
| Accupril 40mg | 01947699 | DT9591 | 2023-03-31 | 2022-04-21 |
| Accupril 40mg | 01947699 | CM2828 | 2022-05-31 | 2022-04-21 |
| Accupril 40mg | 01947699 | CM2829 | 2022-05-31 | 2022-04-21 |
| Accuretic 10/12.5mg | 02237367 | FM9526 | 2023-08-31 | 2022-03-03 |
| Accuretic 10/12.5mg | 02237367 | FA3736 | 2022-07-31 | 2022-03-03 |
| Accuretic 10/12.5mg | 02237367 | EJ5192 | 2022-07-31 | 2022-03-03 |
| Accuretic 20/12.5mg | 02237368 | EX4411 | 2022-07-31 | 2022-03-03 |
| Accuretic 20/12.5mg | 02237368 | ET9511 | 2022-07-31 | 2022-03-03 |
| Accuretic 20/12.5mg | 02237368 | EF3087 | 2022-07-31 | 2022-03-03 |
| Accuretic 20/25mg | 02237369 | FA9224 | 2022-07-31 | 2022-03-03 |
| Accuretic 20/25mg | 02237369 | EA0781 | 2022-07-31 | 2022-03-03 |
Issue
UPDATE: April 21, 2022 – Pfizer recalls Accupril blood pressure tablets due to a nitrosamine impurity
Pfizer Canada ULC is recalling all lots of the prescription drug Accupril (quinapril hydrochloride) in 10 mg, 20 mg and 40 mg strengths due to the presence of a nitrosamine impurity (N-nitroso-quinapril) above the acceptable level. Accupril, like the previously recalled Accuretic drug, is used to treat high blood pressure. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.
Original Advisory: March 3, 2022 – Pfizer recalls Accuretic blood pressure tablets due to a nitrosamine impurity
Pfizer Canada ULC is recalling all lots of Accuretic (quinapril hydrochloride and hydrochlorothiazide) medication in 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths due to the presence of a nitrosamine impurity (N-nitroso-quinapril) above the acceptable level.
Accuretic is a prescription drug used to treat high blood pressure. It contains a combination of quinapril hydrochloride and hydrochlorothiazide, which both lower blood pressure.
Long-term exposure to N-nitroso-quinapril at a level above what is considered acceptable may increase the risk of cancer. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. This impurity is not expected to cause harm when ingested at or below the acceptable level. A person taking a drug that contains this impurity at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.
As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients temporarily taking this medication since the potential risk of cancer is with long-term (every day for 70 years) exposure to nitrosamine impurities that exceeds safe levels, which is not what is expected to occur with patients taking the affected medication for a short period of time.
Health Canada is monitoring the effectiveness of the recall and the company’s implementation of any necessary corrective and preventative actions. Should any additional recalls be deemed necessary, Health Canada will update the table and inform Canadians.
What you should do
- Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk.
- Contact your health care provider to discuss other treatment options. There is currently a reduced supply of combination quinapril hydrochloride and hydrochlorothiazide nationally; however, other drug products are available for treating high blood pressure.
- If you have questions about the recall, contact Pfizer Canada ULC at 1-800-463-6001 or www.pfizermedinfo.ca for medical enquiries, and at 1-800-387-4974 for general enquiries.
- Report any health product-related side effects or complaints to Health Canada.
Additional information
Background
Health Canada has been working to address the issue of nitrosamine impurities found in certain medications since the summer of 2018. Companies were directed to complete detailed evaluations of their manufacturing processes and are testing products if their reviews identified a potential for nitrosamine formation. As this work progresses, additional products may be identified and recalled as appropriate. Health Canada continues to work closely with international regulatory partners and companies to address the issue and will continue to keep Canadians informed. More information on Health Canada’s work to address nitrosamines in medications is available on Canada.ca.
Related links
Details
Media and public enquiries
Media Enquiries:
Health Canada
(613) 957-2983
media@hc-sc.gc.ca
Public Enquiries:
(613) 957-2991
1-866 225-0709
info@hc-sc.gc.ca
Get notified
Receive notifications for new and updated recalls and alerts by category.