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 ?
section][section] 301-399f (2012) (prohibiting adulterated and misbranded food, drugs, devices, and cosmetics).
A company's off-label promotional speech provides probative evidence of illicit conduct--the distribution of misbranded drugs--and therefore restrictions of off-label promotion should not trigger First Amendment protection.
214) Accordingly, the district court denied Caronia's motion in its entirety, and ultimately, Caronia was convicted on one count of "conspiracy to introduce or deliver for introduction to interstate commerce a drug, Xyrem, that was misbranded.
The FDCA prohibits misbranding, or "the introduction or delivery for introduction into interstate commerce of" a misbranded drug.
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.
According to the Globe and Mail, Anthony Galea pleaded guilty to a charge of misleading a US agency by introducing misbranded drugs into the US.
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.
The bill would increase the penalties associated with introducing or receiving adulterated or misbranded food, or causing adulteration or misbranding, from up to three years in prison to up to 10 years in prison for intentional violations.
In a letter dated August 30 and released on Tuesday, the regulator said Dr Pepper's Canada Dry Sparkling Green Tea Ginger Ale was misbranded because the product label improperly used the word "enhanced" relating to antioxidants from green tea.
The Food and Drug Administration sent warning letters to the operators of 136 Web sites that were engaged in illegal sale of unapproved or misbranded drugs, according to the agency.
Quest Diagnostics to pay $302M for misbranded test kits.