OTTAWA, ON, Sept. 24, 2020 /CNW/ -
Product: MAR-Diltiazem CD capsules
Issue: MAR-Diltiazem CD capsules are being recalled because of concerns of incorrect dosing.
What to do: Patients using MAR-Diltiazem CD should consult with their doctor or pharmacist as soon as possible to find an alternative product. Patients should not stop taking their medication until they have spoken to their healthcare provider or pharmacist.
Health Canada is informing Canadians that Marcan Pharmaceuticals has recalled all lots of all MAR-Diltiazem CD products in response to data integrity concerns that could lead to incorrect dosing.
MAR-Diltiazem CD is used to treat chronic stable angina and mild to moderate hypertension. Receiving either too much or too little medication could lead to serious adverse health effects.
Health Canada's authorization of Marcan's MAR-Diltiazem CD relied on data generated by Panexcell Clinical Laboratories Priv. Ltd. An inspection of the Panexcell testing site by the European Medicines Agency (EMA), a trusted regulatory partner, raised concerns that the data submitted by the lab for bioequivalence studies of the MAR-Diltiazem CD capsules may have been falsified.
Bioequivalence studies are used to demonstrate that a generic drug produces the same amount of active ingredient in the blood as a brand-name drug. The active ingredient is the substance in the drug that treats illness.
Health Canada has reviewed additional evidence provided by Marcan and concluded that it does not sufficiently establish that the product is bioequivalent to the brand-name drug. As a result, MAR-Diltiazem CD cannot be considered safe and effective and therefore Marcan is not allowed to make any further sales until the company can provide additional information to demonstrate that the product is safe and effective.
What is Health Canada doing
In discussion with Health Canada, the company has initiated a stop sale and voluntary recall of the product until the company can provide additional information to demonstrate that the product is safe and effective.
Health Canada is monitoring the situation and will take appropriate and timely action if any new health risks are identified.
Information for patients:
- Consult your doctor or pharmacist as soon as possible if you are currently using MAR-Diltiazem CD capsules.
- Patients are advised not to stop taking their MAR-Diltiazem CD product until they have spoken to their healthcare provider or pharmacist about possibly obtaining an alternative product for treatment of their medical condition.
- Several alternative drugs are available.
- Report any health product adverse events or complaints to Health Canada.
- If you have any questions about the recall, contact Marcan Pharmaceuticals at 613-228-2600 Ext: 229 or via email firstname.lastname@example.org
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SOURCE Health Canada