NY Dietary Supplement Maker Faces Injunction
BROOKLYN, N.Y. - Triceutical Inc. and its president face an injunction preventing them from distributing its adulterated line of Joint King dietary supplements, a federal judge ruled.
The United States had filed a complaint against Triceutical and its Farmingdale, N.Y.-based president Liqun Zhang last month, alleging violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
Justice Department attorneys said its inspections of Triceutical's manufacturing facility in Farmingdale "revealed, among other things, that Triceutical failed to ensure that components, dietary supplements, packaging and labels were not mixed up, contaminated or deteriorated."
The "defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA," the Justice Department said Wednesday.
"The consent decree requires the dietary supplement manufacturer to cease all operations and requires that if the defendants wish to resume manufacturing dietary supplements in the future, the FDA first must determine that Triceutical's manufacturing practices have come into compliance with the law."
Though the government filed the consent decree with the complaint in June, it docketed the filing Tuesday.
The Justice Department says Joint King, Triceutical's dietary supplement, "was found to contain high levels of Vitamin D."
"A consumer of Joint King experienced headache, confusion and kidney failure resulting in hospitalization due to Vitamin D toxicity," the Justice Department's statement continues.