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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination 7/05/2018

July 8, 2018 By Barry Friedman Leave a Comment

 FDA  advises consumers not to use Blissful Remedies kratom products due to bacterial contamination.  The products are sold by World Organix LLC, Las Vegas, Nevada.  FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Blissful Remedies announced a recall on June 30, 2018. FDA is concerned this recall does not include all lot numbers of the affected products.

FDA has received reports of adverse events associated with kratom products. There are no proven medical uses for kratom and the public is strongly discouraged from consuming kratom. Kratom is an inherently addictive product that can cause harm.

FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any drug products to FDA’s MedWatch Adverse Event Reporting program:

NOTE:  Although I usually do not list Recalls on my Blog site, I believe it is imperative in this particular situation since the FDA indicated that the Recall does not include all lot numbers of the affected products.  Thus, what the FDA is saying within this Recall is that the Company is not working to completely eliminate all possible manufactured lots and no lots should be considered exempt from this Recall.

 

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Filed Under: FDA Compliance, Microbiological Issues, Recall Tagged With: bacterial contamination, Blissful Remedies, kratom, Recall, World Organix

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