Pfizer recall of Inderal-LA (propranolol hydrochloride) capsules

Products: Inderal-LA (propranolol hydrochloride) extended release capsules, in 60 mg, 80 mg, 120 mg and 160 mg strengths

•             Issue: All lots of these products are being recalled due to the presence of a nitrosamine impurity above the acceptable level

•             What to do: 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.

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.

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

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.