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COMPANY ANNOUNCEMENT

PDX Aromatics Expands Recall of Kratom Products Because of Possible Health Risk

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Dietary Supplements
Food & Beverages
Nutritional Supplement
Foodborne Illness
Reason for Announcement:
Recall Reason Description
Potential to be contaminated with Salmonella
Company Name:
PDX Aromatics
Brand Name:
Brand Name(s)
Kraken Kratom, Phytoextractum, & Soul Speciosa
Product Description:
Product Description
White vein powder & capsule red vein powder products

Company Announcement

PDX Aromatics, DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, is expanding the scope of their 3/9/2018 voluntary recall of certain kratom white vein powder and capsule products and red vein powder products because they have the potential to be contaminated with Salmonella. The expanded recall is being initiated in response to additional positive findings of Salmonella associated with Aromatics’ products following the FDA initial investigation.

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.

The expanded recall includes white vein and red vein powder and capsule products shipped between 1/18/2018 and 3/8/2018.

The expanded recalled products were sold directly to internet consumers in the US through the company websites http://phytoextractum.com; http://soulspeciosa.com; and http://krakenkratom.com.

WHITE VEIN powder and capsule EXPANDED recalled products:

Brand Product name Net Wt
Kraken Kratom Maeng Da Thai Kratom Powder (White Vein) 28 g, 56 g, 112 g
Kraken Kratom White Vein Borneo Kratom Powder 28 g, 56 g, 112 g
Kraken Kratom White Vein Sumatra 28 g, 56 g, 112 g
Kraken Kratom White Vein Borneo Kratom Capsules 28 g, 56 g, 112 g
Phytoextractum White Maeng Da Powder 28 g, 56 g, 112 g, 225g
Phytoextractum White Borneo Powder 28 g, 56 g, 112 g, 225 g
Phytoextractum White Vein Sumatra 28 g, 56 g, 112 g
Phytoextractum White Maeng Da Thai Capsules 28 g, 56 g, 112 g
Soul Speciosa Borneo Kratom Powder (White Vein) 28 g, 56 g, 112 g
Soul Speciosa Sumatra Kratom Powder (White Vein) 28 g, 56 g, 112 g
Soul Speciosa White Vein Borneo Kratom Capsules 28 g, 56 g, 112 g

WHITE VEIN powder and capsule EXPANDED recalled products have any of the following LOT codes:

LOT 20180216 LOT 20180221 LOT 20180226 LOT 20180303 LOT 20180308
LOT 20180217 LOT 20180222 LOT 20180227 LOT 20180304  
LOT 20180218 LOT 20180223 LOT 20180228 LOT 20180305  
LOT 20180219 LOT 20180224 LOT 20180301 LOT 20180306  
LOT 20180220 LOT 20180225 LOT 20180302 LOT 20180307  

RED VEIN powder EXPANDED recalled products:

Brand Product name Net Wt
Kraken Kratom Red Dragon Kratom Powder 28 g, 56 g, 112 g
Kraken Kratom Red Vein Borneo Kratom Powder 28 g, 56 g, 112 g
Kraken Kratom Red Vein Sumatra Kratom Powder 28 g, 56 g, 112 g
Kraken Kratom Red Vein Thai Kratom Powder 28 g, 56 g, 112 g
Kraken Kratom Super Indo Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Maeng Da Thai Kratom Powder (Horn Red) 28 g, 56 g, 112 g
Phytoextractum Red Dragon Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Red Vein Borneo Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Red Vein Sumatra Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Red Vein Thai Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Super Indo Kratom Powder 28 g, 56 g, 112 g
Soul Speciosa Maeng Da Thai Kratom Powder (Horn Red) 28 g, 56 g, 112 g
Soul Speciosa Red Dragon Kratom Powder 28 g, 56 g, 112 g
Soul Speciosa Red Vein Sumatra Kratom Powder 28 g, 56 g, 112 g
Soul Speciosa Red Vein Thai Kratom Powder 28 g, 56 g, 112 g
Soul Speciosa Super Indo Kratom Powder 28 g, 56 g, 112 g

RED VEIN powder EXPANDED recalled products have any of the following LOT codes:

LOT 20180219 LOT 20180228
LOT 20180220 LOT 20180301
LOT 20180221 LOT 20180302
LOT 20180222 LOT 20180303
LOT 20180223 LOT 20180304
LOT 20180224 LOT 20180305
LOT 20180225 LOT 20180306
LOT 20180226 LOT 20180307
LOT 20180227 LOT 20180308

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

The company is thoroughly communicating the details of the recall and is notifying all customers to return products so they can be destroyed. Any customer who believes they may have product affected by this recall should visit pdxaromatics.com/recall for complete return and refund instructions. Working in cooperation with the FDA, the company will destroy all recalled product upon return.

As a community-focused, family-owned company, PDX Aromatics takes its responsibility to provide safe products for all its customers very seriously. The company is committed to ensuring the safety of all of its products and its facility and has suspended product sales and shipments pending a full quality audit, including thorough cleaning and disinfection processes and extensive testing.

Consumers with questions should contact PDX Aromatics at 503-850-9225, 9AM-5PM PT, Monday through Friday, or at recall@pdxaromatics.com.

Original Press Release

Second Expanded Press Release


Company Contact Information

Consumers:
PDX Aromatics
503-850-9225
recall@pdxaromatics.com
Media:
Jenn Lauder
media@pdxaromatics.com

Product Photos

 
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