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.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
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.
District Court for the Eastern District of New York, a jury in 2008 found Caronia guilty of conspiracy to introduce a misbranded drug into interstate commerce.
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.
The exclusion order was based on misdemeanor guilty pleas by each officer admitting that they had served as "responsible corporate officers" during a five year period for which the company had been convicted of marketing misbranded drugs (OxyContin) with the intent to mislead the FDA.