SteriMax Inc. is recalling OrfenAce 100 mg tablets after testing identified a nitrosamine impurity above what is considered acceptable if the drug were to be taken over a lifetime. OrfenAce (a brand name for orphenadrine citrate) is an over-the-counter muscle relaxant used to relieve muscle spasms. The nitrosamine impurity found in OrfenAce is called NMOA (N-methyl-N-nitroso-2-[(2 methylphenyl) phenylmethoxy]ethanamine). Nitrosamine impurities are possible or probable human carcinogens. This means that long-term exposure to a level above what is considered safe may increase the risk of cancer. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. Health Canada does not expect that a nitrosamine impurity will cause harm when exposure is at or below the acceptable level. For example, no increase in the risk of cancer is expected if exposure to the nitrosamine impurity below the acceptable level occurs every day for 70 years. Health Canada is advising that there is no immediate risk to patients taking this medication since the potential risk of cancer is with long-term (every day for 70 years) exposure to nitrosamine impurities that exceeds safe levels, which is not what is expected to occur with patients taking the affected medication for a short period of time. Patients should seek an alternative muscle relaxant to relieve their muscle spasms. Health Canada is monitoring the effectiveness of the recall and the company’s implementation of any necessary corrective and preventative actions. Should any additional recalls be deemed necessary, Health Canada will update the table below and inform Canadians.
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