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contains filthy, putrid, or decomposed substance


has been prepared or held under unsanitary conditions where it may have been contaminated


methods of manufacture do not conform to GMPs


container is composed of poisonous or deleterious substance which may contaminate the drug


it contains an unsafe color additive


if the strength differs, or it's quality or purity falls below the compendium standard unless the difference is clearly stated on the label or what it represents


mixed or packed with any substance which reduces its strength or quality or the drug has been substituted in whole or in part


labeling is false or misleading


if the label fails to contain the following information: name and address of manufacturer, packer or distributor; name of the drug; net quantity of the drug; weight of active ingredient per dosage unit; "Rx Only"; specific routes of administration; storage instructions; lot number; expiration date; adequate information for use


OTC fails to contain the following information: display panel including identity of product; name and address of the manufacturer, packager, distributor; net quantity of contents; cautions and warning needed to protect user; adequate directions for safe and effective use; "Drug Facts"; active ingredients; purpose; uses; warnings; directions; other information; inactive ingredients in alphabetical order; questions--telephone number


if drug is liable to deterioration unless it is packed or labeled accordingly


container is made, formed, or filled as to be misleading


is an exact imitation of another drug offered for sale under the name of another drug


dangerous to health when used in the dosage or manner suggested by the labeling


is packaged or labeled in violation of the Poison Prevention Packaging Act

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