Medicine recalls
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| The United States: World Organix, LLC issues voluntary nationwide recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, due to high microbial loads contamination |
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The US Food and Drug Administration (FDA) announces that World Organix LLC, is voluntarily recalling lot 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the FDA and found to be contaminated with high microbial loads. Additionally, this serves as a update to a previous press release posted on 30 Jun 2018, concerning Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom+CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, recalled due to Salmonella contamination, where Blissful Remedies was listed as the recalling firm instead of World Organix LLC. To date, World Organix LLC has not received reports of adverse events related to these recalls.
These are unapproved products. The Maeng Da products, containing M. speciose, has psychoactive properties. The 4 Hour Chill Herbal Shot, contains melatonin, which has been reported to treat insomnia. The affected products are as follows:
- Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa: 12 ml; White Plastic Bottle; Lot 112710; Best By Date 06/2019
- Blissful Remedies 4 Hour Chill Slow Motion Blend: 1.93 Fluid Oz (57 ml); White Plastic Bottle; Lot 112710; Best By Date: 03/2019
- Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa: 50 capsules; White Foil Pouch; Lot 112710; Best By Date: 03/2019
- Blissful Remedies Gold Series Ultra Enhanced Indo (100% Mitragyna Speciosa): 50 capsules; White Foil Pouch; Lot 112710; Best By Date: 03/2019
- Blissful Remedies Kratom+CBD, CBD infused Maeng Da: 50 capsules; White Foil Pouch; Lot 112710; Best By Date: 03/2019
Immunodeficient individuals have a higher probability of developing a disseminated potentially life threatening infection when ingesting or otherwise orally exposed to solutions contaminated by microorganisms. Salmonella, is a microbial 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm616749.htm
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product containing kratom. Related news was previously issued by FDA, and was posted on the Drug Office website on 3 Jul 2018 and 6 Jul 2018.
Ends/Tuesday, Aug 14, 2018
Issued at HKT 15:00
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