MAR-Diltiazem CD capsules recalled in Canada

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MAR-Diltiazem CD capsules recalled in Canada Health Canada is advising that all lots of Marcan’s diltiazem [MAR-Diltiazem CD 120, 180, 240 and 300mg capsules] are being recalled in Canada because of concerns that data submitted by Panexcell Clinical Laboratories for bioequivalence studies may have been falsified, resulting in potentially incorrect dosing. Patients receiving treatment with MAR-Diltiazem CD should consult with their doctor or pharmacist to get an alternative diltiazem product. Health Canada has reviewed evidence provided by Marcan and concluded that it does not adequately establish that MAR-Diltiazem CD is bioequivalent to the brand-name drug, and cannot currently be considered safe and effective. Marcan has issued a stop sale and voluntary recall of MAR-Diltiazem CD capsules until it can provide sufficient further data to demonstrate the safety and effectiveness of the product. Health Canada. All strengths of MAR-Diltiazem CD, a drug used to treat angina and hypertension, have been recalled because of dosing concerns. Internet Document : 24 Sep 803506583 2020. Available from: URL: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74021a-eng.php

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Reactions 10 Oct 2020 No. 1825