Summary

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Company Statement

Summitt Labs is willingly recalling Batch #730 Lot #K018 of KORE ORGANIC Watermelon CBD Oil Cast, 30 ml bottle, 15 mg 450 x to the consumer level. The Florida Department of Farming and Customer Providers evaluated a random sample and found the product to consist of lead levels at 4.7 ppm. When notified of this, Summitt Labs provided an immediate voluntary recall and started an internal examination. As part of this examination Summitt Labs had a sample from Batch #730 Lot #K018 evaluated at an ISO/IEC certified laboratory. Lead outcomes were 500 ppb (.5 ppm), which is within the legal limitations as specified by the State of Florida. Nevertheless, based on the test from the Florida Department of Farming and Customer Providers, Summitt Labs started, and will finish, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Customer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Customer Services to produce products consisting of CBD however the Federal Food and Drug Administration does rule out CBD to be a legal drug or dietary supplement.

Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 consisting of lead could lead to high lead direct exposure. According to the Florida Department of Health, acute lead poisoning could have symptoms and signs consisting of but not restricted to; Pain, Muscle Weak Point, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor cravings, Weight Loss, Signs connected with sleeping sickness, Metal taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, grievance or report of any adverse effect from the use of this item.

The item labels states that benefits might consist of, Anxiety Relief, Discomfort Decrease, Mood Enhancer, Peaceful Sleep and might Minimize Tension. The Product can be identified by the Kore Organic Logo Design and Kraft Paper Packaging on the 30 milliliter bottle. The product was distributed across the country by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Personnel, Tradeshow Samples, and by Summitt Labs.

Summitt Labs is notifying its suppliers and clients by e-mail, phone, and individual sees to ensure the return of all remembered item. Customers, suppliers and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop utilizing the item.

Any consumer with Lot #K018 Batch #730 in their possession are prompted to contact Summitt Labs by phone at (833) 810-5673 Monday-Friday 8a. m. to 5p. m. EST, or through the site at www.Koreorganic.com. Any customer with Lot #K018 Batch #730 must return this item to the place of purchase for a complete financial refund. If that is rejected, please contact Summitt Labs at the above number for refund information and any other information regarding this recall. Customers must contact their doctor or healthcare provider if they have actually experienced any problems that might be connected to taking or using this drug product. Media with any questions about this recall should get in touch with Christopher Cardamone, Esq. at (813) 842-7266 Monday-Friday 8 a.m. to 5p. m. EST.

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

• Total and send the report Online
• Regular Mail or Fax: Download type or call 1- 800-332-1088 to ask for a reporting kind, then complete and return to the address on the pre-addressed form, or send by fax to 1-800- FDA-0178
• Negative effects and unfavorable reactions handling high levels of lead can be seen at www.Floridahealth.gov
• This recall is being performed with the understanding of the U.S. Food and Drug Administration.

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