Safety

Company Announcement

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.

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

For Immediate Release

June 30, 2018

Contact

Consumers

Customer Support
fdarecall@blissfulremedies.com
1-800-435-8533
 

Announcement

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.

These products have 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, infect ion 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 product is used as Nevada and is packaged in white foil pouches with Lot No.: 112710 and expiration 03/2019 . The affected products are as follows:

Products LabelSizePackaging
Red Maeng Da (100% Mitragyna
Speciosa)
50 capsulesWhite Foil Pouches
Gold Series Ultra Enhanced Indo
(100% Mitragyna Speciosa)
50 capsulesWhite Foil Pouches
Kratom+CBD., CBD infused
Maeng Da
50 capsulesWhite Foil Pouches

These products were distributed to retail stores located in AK, AZ, CA, FL, GA, HI, IL, KS, KY, CT, MA, MI, MN, MO, MS, NE, NJ, NM, NY, OH, OK, PA, PR, SD, TX, VA.

Blissful Remedies is notifying its retailers by e-mail and/or telephone and customers are urged to return the recalled products to us or immediately discard them for credit.

Consumers with questions regarding this recall can contact the company at fdarecall@blissfulremedies.com or 1-800-435-8533 , 9 am to 6 pm (Central Time Zone), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Product Photos

Blissful Remedies, Red Maeng DA, 100% Mitragyna Speciosa, 50 Capsules

Blissful Remedies, Gold Series, Ultra Enhanced Indo, 50 Capsules

Blissful Remedies, Kratom + CBD, CBD Infused Maeng DA, 50 Capsules, 2 mg CBD per capsule

Page Last Updated: 08/14/2018
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