Why was orphenadrine discontinued? Unpacking the nitrosamine recall and safety concerns
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3 min read
In March 2022, manufacturer Sandoz, Inc. issued a nationwide recall of 13 lots of orphenadrine citrate 100 mg extended-release tablets because of a potentially cancer-causing nitrosamine impurity. However, the story of why was orphenadrine discontinued is more complex, involving long-standing safety concerns and poor risk-benefit ratios that ultimately led to its removal from many markets.
