Public Advisory - NRA-Amlodipine 5 mg tablets: One lot recalled as some bottles may contain the wrong drug
Summary
Affected products
Issue
Nora Pharma is recalling one lot of NRA-Amlodipine 5 mg tablets because some bottles may contain the wrong tablets, which have been identified as metoprolol succinate prolonged–release 12.5 mg tablets.
NRA-Amlodipine treats high blood pressure and chest pain in adults and children aged 6 to 17. The tablets are white or off-white, octagonal, flat, and scored in the middle with '210' and '5' on one side.
The metoprolol succinate prolonged-release 12.5 mg tablets are white, round and scored in the middle.
While metoprolol is also used to treat high blood pressure and chest pain, substituting amlodipine (5 mg) with metoprolol (12.5 mg) can lead to serious side effects such as dangerous blood pressure changes (especially dangerously low drops), difficulty breathing, or an abnormally slow heart rate.
Patients with other conditions (especially heart failure, asthma, severe peripheral arterial disease, pheochromocytoma, or diabetes) and those taking other medications could experience different side effects with varying levels of severity.
Children taking the wrong medication may face a higher risk of serious side effects and potential harm.
Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions to stop this issue from reoccurring. The Department will inform the public if any new health risks are identified.
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