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The primary sources for this report include: Recalls (Enforcement Reports Database)+ The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified." While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls

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They do not establish outcomes for a suppliers research product, an independently manufactured pen or vial, a different formulation or concentration, an unmonitored individual or a material represented only by a certificate