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In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death." Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences

Over the next following 10 years, transaminases fluctuated between 50 and 500 U/L

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Thyroid tumors: There is a potential risk noted in animal studies, though human studies have not confirmed this