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Apotex Recalls One Lot of Organ Rejection Drug Due to Label Error

August 18, 2014

By Reuters Staff

NEW YORK - Privately-held Canadian drug company Apotex Inc is recalling one lot of organ-rejection drug Apo-Mycophenolic Acid due to a labeling 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.

Other symptoms of an over-dose include blood abnormalities and stomach problems, the statement said.

As of August 15, no adverse reactions had been reported to either Apotex or to Health Canada, however.

The statement did not make clear how many dosages of the drug were in one lot, and both Apotex and Health Canada were not available to comment.


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