Apotex recalls Apo-Mycophenolic Acid due to labeling error

Canadian drug company Apotex is recalling one lot (KY6601) of Apo-Mycophenolic Acid due to a package labeling error. The product is used to prevent organ rejection in patients receiving a kidney transplant and is sold only in Canada.

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 labeling for the 360 mg strength.

If a patient takes a higher dose due to the labelling error, it could result in over suppression 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. Till date, no adverse reactions related to this issue had been reported to either Apotex or to Health Canada.