Summary

Company Announcement Date: April 22, 2018 FDA Publish Date: April 06, 2020 Product Type: Food & Beverages

Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: NutriZone, LLC Brand Name: Brand Name(s) Various: Pain Out, Nirvanio, Cali Product Description: Product Description various kratom dietary supplements

Company Announcement

NutriZone, LLC of Houston, Texas is expanding its recall of various kratom dietary supplements to all lots sold, which may contain the same source material as the original recalled lots. The expanded recall is being conducted out of an abundance of caution.

The recall of dietary supplements is due to the potential for contamination with 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 this product should contact their healthcare providers.

The dietary supplements are labeled and packaged as follows:

Product Name Net Quantity

(Capsules Per Container) Lot Number Packaging Cali Green Malay All All All Cali Maeng Da All All All Cali Thai All All All Nirvanio Bali All All All Nirvanio Green Malay All All All Nirvanio Maeng Da All All All Nirvanio Special Reserve All All All Pain Out Green Malay All All All Pain Out Maeng Da All All All Pain Out Thai All All All

Attached are images of product labels to aide in identifying product associated with this recall. Lot numbers can be found on the packaging near the Nutrition Facts Panel.

The products were sold Nationwide (FL, CA, OK, GA, SC, PA, LA, WA, MS, MO, KY, AZ, CO, TX, NY, IL).

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella.

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.

Company Contact Information Consumers: NutriZone, LLC 1-800-936-7936