Apotex recalls one lot of organ rejection drug

Privately-held Canadian drug company Apotex Inc is recalling one lot of organ-rejection drug Apo-Mycophenolic Acid due to a labelling error, according to a statement from Health Canada released on Saturday. The product is used to prevent organ rejection in patients receiving a kidney transplant and is sold only in Canada. Apotex's recall of the drug was done in consultation with Health Canada, a Canadian federal agency, the statement said.
The French-language statement on the outer carton of the drug indicated that each tablet contains 180 milligrams of the medicine, but the actual strength of the tablets in the package is 360 mg, it said. The rest of the carton, the leaflets, the blister labels, and the dosing instructions all provided the correct dosage, the statement said. A too-high dose of the drug could result in over-suppression of the immune system and lead to increased risk of infection, which in the worst case scenario could cause death, it said.