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
The likely groups to avoid it, still being studied, include people with a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2, severe stomach-emptying problems, type 1 diabetes, or pregnancy
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7 Ayala et al
TB-500: The Thymosin Beta-4 fragment presents a comparable safety profile
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