FDA News

FDA: PDX Aromatics recalls kratom-containing powder products for risk of Salmonella

The FDA has announced that PDX Aromatics of Portland, Oregon, has begun a recall of products containing kratom powder, an unregulated herbal supplement, which has the potential to be contaminated with Salmonella.

In February, the CDC linked a multistate outbreak of Salmonella infections to kratom, which the agency said is consumed for stimulant effects and as an opioid substitute. In an update on March 2, the CDC announced that the outbreak had sickened 40 people in 27 states, leading to 14 hospitalizations. Patients ranged in age from 6 to 67 years, and no deaths have been reported.

The outbreak strain of Salmonella 1:4,[5],12:b was identified using two samples of leftover kratom powder collected from ill patients in North Dakota and Utah.

The CDC reported that kratom is a plant native to Southeast Asia that is brewed in tea, chewed, smoked or ingested in capsules.

The recalled products are sold under the brand names of Kraken Kratom, Phytoextractum and Soul Speciosa. The powder products are packed in plastic heat-sealed pouches and come in sizes of 28 g, 56 g and 112 g.

PDX Aromatics reports that the affected products total an estimated 10,000 units and were sold to consumers through company websites from Jan. 18, 2018, to Feb. 18, 2018.

The FDA WebWatch and PDX Aromatics website lists specific names of the recalled products and LOT codes 20180118-20180218, which represent the packaging dates.

Consumers in possession of the recalled products are advised not to consume the products and to return them to PDX Aromatics. Patients and health care professionals are advised to report adverse events related to the products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Before identifying PDX Aromatics as a possible source of Salmonella contamination, the CDC warned people not to consume kratom in any form and to talk to a health care provider before taking any supplement, especially if they are in a group likely to get a severe Salmonella infection.

“These groups include people with weakened immune systems, including people who are receiving chemotherapy or have HIV, pregnant women, children younger than 5 years, and older adults,” the CDC reported.

 

References:

CDC. Multistate Outbreak of Salmonella I 4,[5],12:b:- Infections Linked to Kratom. https://www.cdc.gov/salmonella/kratom-02-18/index.html. Accessed March 12, 2018.

FDA. MedWatch. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm600613.htm. Accessed March 12, 2018.

North Dakota Department of Health. https://health.nd.gov/media/1997/2018-3-2-nddoh-warns-against-consuming-kratom.pdf. Accessed March 12, 2018.

PDX Aromatics. https://www.pdxaromatics.com/. Accessed March 12, 2018.

Utah Department of Health. https://health.utah.gov/featured-news/utah-public-health-is-investigating-salmonella-infections-linked-to-kratom. Accessed March 12, 2018

The FDA has announced that PDX Aromatics of Portland, Oregon, has begun a recall of products containing kratom powder, an unregulated herbal supplement, which has the potential to be contaminated with Salmonella.

In February, the CDC linked a multistate outbreak of Salmonella infections to kratom, which the agency said is consumed for stimulant effects and as an opioid substitute. In an update on March 2, the CDC announced that the outbreak had sickened 40 people in 27 states, leading to 14 hospitalizations. Patients ranged in age from 6 to 67 years, and no deaths have been reported.

The outbreak strain of Salmonella 1:4,[5],12:b was identified using two samples of leftover kratom powder collected from ill patients in North Dakota and Utah.

The CDC reported that kratom is a plant native to Southeast Asia that is brewed in tea, chewed, smoked or ingested in capsules.

The recalled products are sold under the brand names of Kraken Kratom, Phytoextractum and Soul Speciosa. The powder products are packed in plastic heat-sealed pouches and come in sizes of 28 g, 56 g and 112 g.

PDX Aromatics reports that the affected products total an estimated 10,000 units and were sold to consumers through company websites from Jan. 18, 2018, to Feb. 18, 2018.

The FDA WebWatch and PDX Aromatics website lists specific names of the recalled products and LOT codes 20180118-20180218, which represent the packaging dates.

Consumers in possession of the recalled products are advised not to consume the products and to return them to PDX Aromatics. Patients and health care professionals are advised to report adverse events related to the products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Before identifying PDX Aromatics as a possible source of Salmonella contamination, the CDC warned people not to consume kratom in any form and to talk to a health care provider before taking any supplement, especially if they are in a group likely to get a severe Salmonella infection.

“These groups include people with weakened immune systems, including people who are receiving chemotherapy or have HIV, pregnant women, children younger than 5 years, and older adults,” the CDC reported.

 

References:

CDC. Multistate Outbreak of Salmonella I 4,[5],12:b:- Infections Linked to Kratom. https://www.cdc.gov/salmonella/kratom-02-18/index.html. Accessed March 12, 2018.

FDA. MedWatch. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm600613.htm. Accessed March 12, 2018.

North Dakota Department of Health. https://health.nd.gov/media/1997/2018-3-2-nddoh-warns-against-consuming-kratom.pdf. Accessed March 12, 2018.

PDX Aromatics. https://www.pdxaromatics.com/. Accessed March 12, 2018.

Utah Department of Health. https://health.utah.gov/featured-news/utah-public-health-is-investigating-salmonella-infections-linked-to-kratom. Accessed March 12, 2018