Pfizer recalls Inderal-LA (propranolol hydrochloride) capsules due to a nitrosamine impurity
Summary
Contact your health care provider to discuss other treatment options. While there are no other companies marketing extended release propranolol in Canada, immediate release propranolol products continue to be available, along with other treatment options. Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition poses a greater health risk.
Affected products
| Product | DIN | Lot | Expiry |
|---|---|---|---|
| Inderal-LA 60 mg | 02042231 | EX7461 | 2024-01-31 |
| Inderal-LA 60 mg | 02042231 | EH5907 | 2023-08-31 |
| Inderal-LA 60 mg | 02042231 | DX6150 | 2023-03-31 |
| Inderal-LA 80 mg | 02042258 | EX7462 | 2024-01-31 |
| Inderal-LA 80 mg | 02042258 | EL1695 | 2023-08-31 |
| Inderal-LA 80 mg | 02042258 | EE7221 | 2023-05-31 |
| Inderal-LA 80 mg | 02042258 | DW8242 | 2023-03-31 |
| Inderal-LA 80 mg | 02042258 | DJ2768 | 2022-09-30 |
| Inderal-LA 120 mg | 02042266 | FE0541 | 2024-01-31 |
| Inderal-LA 120 mg | 02042266 | EH5908 | 2023-08-31 |
| Inderal-LA 120 mg | 02042266 | DX6159 | 2023-03-31 |
| Inderal-LA 120 mg | 02042266 | DJ6820 | 2022-09-30 |
| Inderal-LA 160 mg | 02042274 | FE6304 | 2024-01-31 |
| Inderal-LA 160 mg | 02042274 | EH5906 | 2023-08-31 |
| Inderal-LA 160 mg | 02042274 | DW8241 | 2023-03-31 |
Issue
Pfizer Canada ULC is recalling all lots of Inderal-LA (propranolol hydrochloride) extended release capsules, in 60 mg, 80 mg, 120 mg and 160 mg strengths, due to the presence of a nitrosamine impurity (N-nitroso-propranolol) above the acceptable level.
Inderal-LA is a prescription medication known as a beta-blocker. It is used in adults to treat high blood pressure and prevent angina pectoris (a condition associated with sharp chest pain and difficulty breathing, often associated with exercise).
Long-term exposure to N-nitroso-propranolol at a level above what is considered safe 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 in continuing to take the recalled Inderal-LA medication since the potential risk of cancer is with long-term exposure (every day for 70 years) to the nitrosamine impurity above the acceptable level. Patients can continue to take their medication as prescribed by their health care provider and do not need to return their medication to their pharmacy, but they should contact their health care provider to discuss other treatment options. While there are no other companies marketing extended release propranolol in Canada, immediate release propranolol continues to be available along with other treatment options/beta blocker medications.
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
- Contact your health care provider to discuss other treatment options, as there are no other companies marketing extended release propranolol in Canada.
- Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition poses a greater health risk.
- Contact Pfizer Canada ULC at 1-800-463-6001 or www.pfizermedinfo.ca for medical inquiries and at 1-800-387-4974 for general inquiries if you have questions about the recall.
- 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
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Health Canada
(613) 957-2983
media@hc-sc.gc.ca
Public Enquiries:
(613) 957-2991
1-866 225-0709
info@hc-sc.gc.ca
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