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  4. PDX Aromatics Issues Second Expanded Recall of Kratom Products Because of Possible Health Risk
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

PDX Aromatics Issues Second Expanded 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:
Food & Beverages
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 again expanding the scope of their 3/9/2018 and 3/15/2018 voluntary recalls to include certain red vein and green vein kratom powder and capsule products because they have the potential to be contaminated with Salmonella. The second expanded recall is being initiated in response to additional positive findings of Salmonella associated with PDX Aromatics’ products following the FDA’s investigation.

To date the company is aware of four confirmed cases of Salmonella associated with consumption of red and white vein products.

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 certain red vein powder and capsule products shipped between 12/1/2017 and 3/8/2018 and certain green vein powder and capsule products shipped between 9/18/2017 and 11/1/2017 and between 2/9/2018 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.

Recalled products were sold to two customers in the United Kingdom and to one customer in each of the following countries: Ireland, Japan, Norway, and Turkey.

RED VEIN powder and capsule EXPANDED recalled products:

Brand Product name Net Wt
Kraken Kratom Red Maeng Da Powder 28 g, 56 g, 112 g
Kraken Kratom Red Maeng Da Capsules 28 g, 56 g, 112 g
Phytoextractum Red Maeng Da Thai Powder 28 g, 56 g, 112 g, 225g
Phytoextractum Red Maeng Da Thai Capsules 28 g, 56 g, 112 g
Soul Speciosa Red Maeng Da Powder 28 g, 56 g, 112 g
Soul Speciosa Red Maeng Da Capsules 28 g, 56 g, 112 g

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

LOT 20171201 LOT 20171221 LOT 20180110 LOT 20180130 LOT 20180219
LOT 20171202 LOT 20171222 LOT 20180111 LOT 20180131 LOT 20180220
LOT 20171203 LOT 20171223 LOT 20180112 LOT 20180201 LOT 20180221
LOT 20171204 LOT 20171224 LOT 20180113 LOT 20180202 LOT 20180222
LOT 20171205 LOT 20171225 LOT 20180114 LOT 20180203 LOT 20180223
LOT 20171206 LOT 20171226 LOT 20180115 LOT 20180204 LOT 20180224
LOT 20171207 LOT 20171227 LOT 20180116 LOT 20180205 LOT 20180225
LOT 20171208 LOT 20171228 LOT 20180117 LOT 20180206 LOT 20180226
LOT 20171209 LOT 20171229 LOT 20180118 LOT 20180207 LOT 20180227
LOT 20171210 LOT 20171230 LOT 20180119 LOT 20180208 LOT 20180228
LOT 20171211 LOT 20171231 LOT 20180120 LOT 20180209 LOT 20180301
LOT 20171212 LOT 20180101 LOT 20180121 LOT 20180210 LOT 20180302
LOT 20171213 LOT 20180102 LOT 20180122 LOT 20180211 LOT 20180303
LOT 20171214 LOT 20180103 LOT 20180122 LOT 20180212 LOT 20180304
LOT 20171215 LOT 20180104 LOT 20180124 LOT 20180213 LOT 20180305
LOT 20171216 LOT 20180105 LOT 20180125 LOT 20180214 LOT 20180306
LOT 20171217 LOT 20180106 LOT 20180126 LOT 20180215 LOT 20180307
LOT 20171218 LOT 20180107 LOT 20180127 LOT 20180216 LOT 20180308
LOT 20171219 LOT 20180108 LOT 20180128 LOT 20180217  
LOT 20171220 LOT 20180109 LOT 20180129 LOT 20180218  

GREEN VEIN powder and capsule recalled products:

Brand Product name Net Wt
Kraken Kratom OG Bali Powder 28 g, 56 g, 112 g
Kraken Kratom Bali Capsules 28 g, 56 g, 112 g
Kraken Kratom Super Green Malaysian Kratom Powder 28 g, 56 g, 112 g
Phytoextractum OG Bali Powder 28 g, 56 g, 112 g, 225 g
Phytoextractum OG Bali Capsules 28 g, 56 g, 112 g
Phytoextractum Green Vein Thai Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Super Green Malaysian Kratom Powder 28 g, 56 g, 112 g
Soul Speciosa OG Bali Powder 28 g, 56 g, 112 g
Soul Speciosa Bali Capsules 28 g, 56 g, 112 g
Soul Speciosa Thai Kratom Powder (Green Vein) 28 g, 56 g, 112 g
Soul Speciosa Super Green Malaysian Kratom Powder 28 g, 56 g, 112 g

GREEN VEIN powder and capsule recalled products listed above have any of the following LOT codes:

LOT 20180209 LOT 20180219  LOT 20180301
LOT 20180210 LOT 20180220  LOT 20180302
LOT 20180211 LOT 20180221  LOT 20180303
LOT 20180212 LOT 20180222  LOT 20180304
LOT 20180213 LOT 20180223  LOT 20180305
LOT 20180214 LOT 20180224  LOT 20180306
LOT 20180215 LOT 20180225  LOT 20180307
LOT 20180216 LOT 20180226  LOT 20180308
LOT 20180217 LOT 20180227  
LOT 20180218 LOT 20180228  

Additionally, the GREEN VEIN powder products listed below have any of the following LOT codes:

Brand Product name Net Wt
Kraken Kratom Super Green Malaysian Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Super Green Malaysian Kratom Powder 28 g, 56 g, 112 g
Phytoextractum Green Vein Thai Powder 28 g, 56 g, 112 g
Soul Speciosa Thai Kratom Powder (Green Vein) 28 g, 56 g, 112 g
Soul Speciosa Super Green Malaysian Kratom Powder 28 g, 56 g, 112 g
LOT 20170918 LOT 20170930  LOT 20171012  LOT 20171024
LOT 20170919 LOT 20171001  LOT 20171013  LOT 20171025
LOT 20170920 LOT 20171002  LOT 20171014  LOT 20171026
LOT 20170921 LOT 20171003  LOT 20171015  LOT 20171027
LOT 20170922 LOT 20171004  LOT 20171016  LOT 20171028
LOT 20170923 LOT 20171005  LOT 20171017  LOT 20171029
LOT 20170924 LOT 20171006  LOT 20171018  LOT 20171030
LOT 20170925 LOT 20171007  LOT 20171019  LOT 20171031
LOT 20170926 LOT 20171008  LOT 20171020  LOT 20171101
LOT 20170927 LOT 20171009  LOT 20171021  
LOT 20170928 LOT 20171010  LOT 20171022  
LOT 20170929 LOT 20171011 LOT 20171023  

PDX Aromatics has identified multiple suppliers in their supply chain as the sources of Salmonella. The company has removed additional suppliers from their supply chain, is resolving potential sources of contamination in its supply, and is removing all affected products.

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

First Expanded Press Release

 

Company Contact Information

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