Home Drugs Information FDA Alert: Kratom-containing Powder Products by PDX Aromatics: Recall

FDA Alert: Kratom-containing Powder Products by PDX Aromatics: Recall


March 12, 2018

Audience: Consumer

[Posted 03/12/2018]

ISSUE: PDX Aromatics of Portland, Oregon DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, has initiated a recall of certain kratom-containing powder products because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

See the press release for affected products, lot codes, and photos.

BACKGROUND: PDX Aromatics identified a supplier in their supply chain as the source of Salmonella. The company has removed that supplier and all associated products from its facility.

RECOMMENDATION: Consumers who may be in possession of potentially contaminated products are advised not to consume products labeled with the affected product descriptions and lot codes. All products associated with this recall should be returned to PDX Aromatics.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/10/2018 – Press Release – PDX Aromatics]

Source link

Previous articleA Win for Hypertension Intervention in Black Barbershops (CME/CE)
Next articleNewer gout drug poses risk to heart patients
Dr Irfanullah Khan Born: 15th July,1994 in Khagram,Dir Upper KPK Pakistan. Others names:Doctor Irfo,Peshoo Education:Pharm-D Scholar Graduated from Abasyn University Peshawar. Occupation:Clinical Pharmacist,Doctor,Entrepreneur. Home Town:Dir Upper Height: 6 feet. Website:Iukmedonline.com


Please enter your comment!
Please enter your name here