Medicine recalls
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| Canada: All strengths of MAR-Diltiazem CD, a drug used to treat angina and hypertension, have been recalled because of dosing concerns |
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Health Canada announces 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. The affected products are:
- MAR-Diltiazem CD 120mg Capsules
- MAR-Diltiazem CD 180mg Capsules
- MAR-Diltiazem CD 240mg Capsules
- MAR-Diltiazem CD 300mg Capsules
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, 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.
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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74021a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 22 Sep 2020.
Ends/Friday, Sep 25, 2020
Issued at HKT 15:00
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