Product Wiki · Recalls · Government of Canada recall portal

Apotex recalling one — recall 52279

Government of Canada recall portal · Canada · 2014-08-16

As described by Government of Canada recall portal: Apotex recalling one lot of Apo-Mycophenolic Acid due to French labelling error

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Government of Canada recall portal
Recall identifier
52279
Date of alert
2014-08-16
Country / jurisdiction
Canada
Risk type
recall
Product category
Health products
Product type
Communications and Public Affairs Branch
Notice status
Archived by the issuing authority — kept for reference
Reported risk: August 16, 2014 For immediate release OTTAWA – Apotex, in consultation with Health Canada, is recalling one lot (KY6601) of Apo-Mycophenolic Acid due to a package labelling error. The product is used to prevent organ rejection in patients receiving a kidney transplant. The French statement on the outer carton indicates that each tablet contains 180 mg of the medicine. The actual tablets in the package contain the correct strength of 360 mg. The rest of the carton, the leaflets, the blister labels and the dosing instructions all contain the appropriate labelling for the 360 mg strength. In the unlikely event that a patient takes a higher dose due to the labelling error, it could result in oversuppression of the immune system and may lead to increased risk of infection causing a serious or fatal outcome. Other symptoms include blood abnormalities and stomach problems. As of August 15, 2014, no adverse reactions related to this issue had been reported to either Apotex or to Health Canada. Patients taking Apo-Mycophenolic Acid should check the label and if there is any confusion about the dose, they should consult with their pharmacist. Patients should also consult with their healthcare practitioners should they have any concerns. Health Canada will monitor Apotex's recall and will inform Canadian should new safety information arise. -30-
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/apotex-recalling-one-lot-apo-m

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.