Safety

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

UPDATED 04/20/2018. NutriZone, LLC expanded its recall of various kratom dietary supplements to additional lot numbers, which contain the same source material as the original recalled lots. The expanded recall is being conducted out of an abundance of caution. For affected lot numbers, see the recall.

[Posted 04/03/2018]

AUDIENCE: Consumer

ISSUE: NutriZone, LLC is recalling 4 different dietary supplements because it has the potential to be contaminated with Salmonella. The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with these products should contact their healthcare providers.

  • Pain Out Maeng Da
  • Pain Out Thai
  • Pain Out Malay
  • Nirvanio Green Malay

BACKGROUND: The products were sold in Pennsylvania, Oklahoma, Washington, Missouri, Florida, Mississippi, California and Texas.

RECOMMENDATION: Consumers who have purchased the products listed above should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers with questions may contact NutriZone, LLC at 1-800-936-7936, Monday through Friday, 9am-5pm Central Standard time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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

[03/30/2018 - Press Release - NutriZone]

Page Last Updated: 04/20/2018
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