- Company Statement Date:
- FDA Release Date:
- Item Type:
- Reason for Announcement:
Remember Reason Description
- Business Name:
- Summitt Labs
- Brand Name:
- Product Description:
Watermelon CBD oil tincture
Summitt Labs is willingly remembering Batch #730 Lot #K018 of KORE ORGANIC Watermelon CBD Oil Cast, 30 ml bottle, 15 mg 450 x to the customer level. The Florida Department of Farming and Customer Solutions checked a random sample and found the item to include lead levels at 4.7 ppm. When notified of this, Summitt Labs provided an immediate voluntary recall and started an internal investigation. As part of this examination Summitt Labs had a sample from Batch #730 Lot #K018 evaluated at an ISO/IEC recognized laboratory. Lead results were 500 ppb (.5 ppm), which is within the legal limits as defined by the State of Florida. Based on the test from the Florida Department of Agriculture and Customer Solutions, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Farming and Customer Services.
Summitt Labs is a checked and certified center under the Florida Department of Food and Farming and Consumer Services to produce items consisting of CBD however the Federal Fda does not consider CBD to be a legal drug or dietary supplement.
Intake of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 including lead might result in high lead exposure. According to the Florida Department of Health, intense lead poisoning might have signs and symptoms consisting of however not restricted to; Discomfort, Muscle Weak Point, Paresthesia, Abdominal Pain, Queasiness, Throwing Up, Diarrhea, Irregularity, Poor cravings, Weight reduction, Signs connected with sleeping sickness, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, grievance or report of any negative result from using this item.
The item labels states that benefits might include, Anxiety Relief, Pain Decrease, State Of Mind Enhancer, Peaceful Sleep and might Relieve Tension. The Product can be identified by the Kore Organic Logo Design and Kraft Paper Packaging on the 30 milliliter bottle. The product was dispersed 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 informing its distributors and consumers by email, phone, and individual visits to guarantee the return of all remembered product. Consumers, suppliers and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being remembered, need to stop using the item.
Any customer with Lot #K018 Batch #730 in their ownership are urged to contact Summitt Labs by phone at (833) 810-5673 Monday-Friday 8a. m. to 5p. m. EST, or through the website at www.Koreorganic.com. Any consumer with Lot #K018 Batch #730 must return this product to the location of purchase for a full financial refund. If that is rejected, please contact Summitt Labs at the above number for refund info and any other info concerning this recall. Customers must contact their doctor or healthcare provider if they have experienced any issues that may be associated with 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.
Unfavorable reactions or quality issues experienced with using this item may be reported to the FDA’s MedWatch Unfavorable Event Reporting program either online, by routine mail or by fax.
- Total and send the report Online
- Routine Mail or Fax: Download type or call 1- 800-332-1088 to ask for a reporting kind, then total and go back to the address on the pre-addressed type, or submit by fax to 1-800- FDA-0178
- Negative effects and adverse reactions dealing with high levels of lead can be seen at www.Floridahealth.gov
- This recall is being conducted with the understanding of the U.S. Fda.
Company Contact Information
- Sameer Jessani
- (404) 840-6337
- Christopher Cardamone, Esq
- (813) 842-7266