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The Food and Drug Administration has asked Primus Pharmaceuticals to recall a product touted to address “the metabolic processes associated with osteoarthritis” but that the agency says
comes with a risk of liver injury and a lung condition.
Primus markets the product, Limbrel, as a “medical food” — a distinct regulatory category — but this week, the FDA said it considers Limbrel to be an unapproved drug. The FDA cannot require
the company to recall Limbrel.
Primus did not immediately respond to a request for comment.
