Canadian pharmaceutical company Apotex Inc. in collaboration with Health Canada has recalled one lot (Lot # KY6601) of Apo-Mycophenolic Acid 360 mg tablets.

The product is being recalled due to an incorrectly labelled tablet strength on the French side panel of the Blister Carton of the 120 tablet pack, which may pose a risk of potential dosing error.

The English version is accurate and identifies the strength correctly as 360 mg tablets. The French side panel incorrectly states 180 mg instead of 360 mg however, the dosage directions in the French statement are correct. The tablet strength indicated on the inner blister packs are correctly labelled, and each tablet is engraved with “MYC 360” on one side.

Healthcare practitioners should be aware that the tablet strength indicated on the French side panel of the Blister Carton of the 120 tablet pack incorrectly states 180 mg instead of 360 mg, posing a risk of potential dosing error.

In the event that the patient takes more than the recommended dose, potential adverse effects include over suppression of the immune system and increased susceptibility to infections (including opportunistic infections, fatal infections and sepsis), hematological abnormalities and gastrointestinal symptoms.

Apo-Mycophenolic Acid is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids. The recommended adult dose is 720 mg twice a day for a total daily dose of 1440 mg.

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.

Any case of dosing error or other serious or unexpected adverse reactions in patients receiving Apo-Mycophenolic Acid tablets should be reported to Apotex Inc.or Health Canada.

Apotex is an independent, dynamic, Canadian pharmaceutical company committed to R&D, manufacturing and distributing a broad range of high-quality, affordable medicines to patients, healthcare providers, payers and governments worldwide.