misbranded


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misbranded

adjective Referring to a drug or device for which its producer makes false or misleading claims.

A product is regarded as mislabeled if:
• The package does not have a label containing the name and address of the manufacturer;
• Wording required by law is not prominently placed on the label;
• It contains narcotic or hypnotic substances and does not contain the statement “warning—may be habit forming”;
• It does not contain the non-proprietary or established name recognised by an official compendium;
• It does not contain adequate warning and directions for its use;
• It is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended or suggested in the labelling or advertising; or
• It purports to be an antibiotic, but does not contain the batch number.
References in periodicals archive ?
Wiley's Act prohibited manufacturing and shipping adulterated or misbranded foods in interstate commerce.
Companies are being charged with the sale of misbranded drugs, and the promotional advertising is relevant because it demonstrates a company's intent to introduce its drugs into interstate commerce for off-label uses.
total of 9,265 samples were found to be adulterated and misbranded.
Food and Drug Administration nor the California Department of Public Health found TNS products to be safe for their intended use, and because TNS products omit required disclosures relating to safety concerns, the products have been misbranded under both federal laws and parallel state laws.
The majority explicitly stated that it was not addressing "state design-defect claims that parallel the federal misbranding statute." The dissent recognized that federal law "bars the sale of previously approved drugs if new information comes to light demonstrating that the drug is 'dangerous to health' and thus 'misbranded.'" This was partly the basis on which the dissent rejected the notion that "drug manufacturers have a right to continue to sell a drug free from liability once it has been approved." Additionally, the dissent discredited the FDA's contention that "design-defect claims are pre-empted unless they parallel the FDA's misbranding prohibition," concluding that the FDA's views need not be given weight here.
history--came in a case that centered on the government's claims that the drug company promoted several drugs for off-label uses, rendering the products misbranded and thus illegal under the Food, Drug and Cosmetic Act (FDCA).
EPA inspections of the Daifuku Trading Corp.'s stores in Flushing, New York and Englewood, New Jersey revealed that the company was selling unregistered and misbranded pesticide products, including insect repellents, laundry detergents and disinfectants.
If an entity that is subject to GDUFA's self-identification requirements fails to meet the requirements, all FDF or API products and all FDFs containing APIs manufactured at the facility will be deemed misbranded. Shipment of misbranded products in interstate commerce or importation of them into the U.S.
These two laws prohibit the marketing of adulterated or misbranded cosmetics in interstate commerce.
The company pleaded guilty to two counts of introducing misbranded antidepressant drugs Paxil and Wellbutrin and one charge of failing to report safety data about the diabetes drug Avandia to the Food and Drug Administration (FDA).
The FDA, however, disagreed, claiming the changes "could significantly affect the safety or effectiveness of the device." As a result, the agency deemed Merit Medical's guidewire adulterated and misbranded, and said it did not have either premarket approval or an investigational device exemption to sell the product.
The bill would increase criminal penalties for companies and individuals that knowingly contaminate the food supply by distributing misbranded or tainted food products.