The U.S. Food and Drug Administration Wednesday said that U.S. Marshals, at the agency's request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom.
The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and is worth more than $400,000.
"We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse," said Melinda Plaisier, the FDA's associate commissioner for regulatory affairs.
Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. There are concerns about the toxicity of kratom in multiple organ systems.
Consumption of kratom can lead to several health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation.
Kratom is indicated to have narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.
The FDA warned consumers not to use any products labeled as containing kratom.
In an unrelated incident, Hospira, a Pfizer (PFE) company, announced a voluntary recall of one lot of MAGNESIUM SULFATE IN WATER FOR INJECTION due to a confirmed customer report of an incorrect barcode on the primary bag labeling.
Separately, Dräger recalled the PS500 battery power supply as a software issue causes shorter than expected battery run times. The software issue with the power supply also prevents the appropriate alarm from sounding 5 minutes before the battery runs out of power, and the device shuts down.
If the ventilator shuts down, a patient may not receive necessary oxygen, which could cause patient injury or death.
The recalled device is the optional PS500 battery power supply for Dräger Evita V500 and Babylog VN500 ventilators. It was manufactured from June 1, 2011 to October 30, 2015 and distributed from June 1, 2011 to October 30, 2015.
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