Advisory - Muscle-relaxant OrfenAce 100 mg tablets recalled because of nitrosamine impurity
Retrieved on:
Friday, April 16, 2021
b"Issue:SteriMax Inc. is recalling this product because of a nitrosamine impurity.\nWhat to do:You should seek an alternative muscle relaxant to relieve your muscle spasms.
Key Points:
- b"Issue:SteriMax Inc. is recalling this product because of a nitrosamine impurity.\nWhat to do:You should seek an alternative muscle relaxant to relieve your muscle spasms.
- Talk to your health care provider if you have taken a recalled product and have concerns about your health.\nSteriMax 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.\nThe nitrosamine impurity found in OrfenAce is called NMOA (N-methyl-N-nitroso-2-[(2 methylphenyl) phenylmethoxy]ethanamine).
- Health Canada does not expect that a nitrosamine impurity will cause harm when exposure is at or below the acceptable level.