Inderal-LA: 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
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
---|---|---|---|---|---|
Pfizer Inderal-LA |
Inderal-LA 60mg |
DIN 02042231 |
Capsule (Extended Release) |
Propanolol Hydrochloride 60mg |
EX7461, EH5907, DX6150 |
Pfizer Inderal-LA |
Inderal-LA 80mg |
DIN 02042258 |
Capsule (Extended Release) |
Propanolol Hydrochloride 80mg |
EX7462, EL1695, EE7221, DW8242 |
Pfizer Inderal-LA |
Inderal-LA 120mg |
DIN 02042266 |
Capsule (Extended Release) |
Propanolol Hydrochloride 120mg |
FE0541, EH5908, DX6159, DJ6820 |
Pfizer Inderal-LA |
Inderal-LA 160mg |
DIN 02042274 |
Capsule (Extended Release) |
Propanolol Hydrochloride 160mg |
FE6304, EH5906, DW8241 |
Issue
Presence of impurity N-Nitroso-propanolol above the acceptable concentration limit in affected lots.
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
Previous recalls or alerts
Background
Depth of recall: Wholesalers, Retailers
Details
Pfizer Canada ULC H9J 2M5 |
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