Two lots of MAR-Amlodipine 5 mg tablets recalled as some bottles may contain the wrong drug

Issue

Marcan Pharmaceuticals Inc. is recalling two lots of MAR-Amlodipine 5 mg tablets because some bottles may contain the wrong tablets, which they have identified as midodrine 2.5 mg tablets. MAR-Amlodipine is used to treat high blood pressure and chest pain in adults and children 6 years of age and older. The tablets are white to off-white, flat and eight-sided, with a line across the middle. One side has “210” and “5” printed on it, and the other side is blank. Midodrine 2.5 mg tablets are white, round, and marked with ‘M2’ on one side and have a line across the middle on the other side. Midodrine is used to treat low blood pressure and substituting amlodipine (5 mg) with midodrine (2.5 mg) can lead to serious side effects such as a dangerous increase in blood pressure, dizziness, fainting and organ damage. Patients with other conditions (e.g., pheochromocytoma, glaucoma, or hyperthyroidism) and those taking other medications could experience different side effects with varying levels of severity if they take the midodrine by mistake. Some patients may not experience any symptoms if their blood pressure is elevated, and may only know by measuring their blood pressure. Elevated blood pressure without symptoms can still result in significant harm to a patient. 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.

What you should do

• Immediately check your medication bottle to ensure it only contains MAR-Amlodipine 5 mg tablets. MAR-Amlodipine 5 mg tablets are white to off-white, flat and eight-sided, with a line across the middle. One side has "210" and "5" printed on it, and the other side is blank. Midodrine 2.5 mg tablets are white, round, and marked with 'M2' on one side and have a line down the middle on the other side. If your bottle contains any unusual tablets or if you are unsure, return it to your pharmacy. If you are unable to get a replacement immediately, continue taking your medication as directed but do not take the round tablets.
• MAR-Amlodipine 5 mg tablets are white to off-white, flat and eight-sided, with a line across the middle. One side has "210" and "5" printed on it, and the other side is blank.
• Midodrine 2.5 mg tablets are white, round, and marked with 'M2' on one side and have a line down the middle on the other side.
• If your bottle contains any unusual tablets or if you are unsure, return it to your pharmacy.
• If you are unable to get a replacement immediately, continue taking your medication as directed but do not take the round tablets.
• Contact your health care professional or call 911 if you are dizzy, have unusually high blood pressure or slow heartbeats.
• Seek immediate medical attention if you have chest pain, a sudden headache, an inability to move or feel a part of your body, or impaired speech.
• If you have questions about this recall, contact Marcan Pharmaceuticals Inc. by calling 1-855-627-2261 or by emailing info@marcanpharma.com.
• Report any health product-related side effects or complaints to Health Canada.
• Health care professionals, such as pharmacists, should check packages and bottles labelled MAR-Amlodipine 5 mg (amlodipine besylate) before dispensing to make sure they do not contain midodrine 2.5 mg tablets. Report any unusual bottles or other issues to the company and Health Canada.