Summitt Labs Issues Voluntary Nationwide Remember of KORE ORGANIC Watermelon CBD Oil Due to High Lead Outcomes
- Company Statement Date:
- FDA Publish Date:
- Product Type:
- Factor for Announcement:
Recall Factor Description
- Company Name:
- Summitt Labs
- Item Description:
Watermelon CBD oil cast
Summitt Labs is voluntarily remembering 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 Agriculture and Customer Services evaluated a random sample and discovered the item to contain lead levels at 4.7 ppm. When notified of this, Summitt Labs released an immediate voluntary recall and began an internal investigation. As part of this examination Summitt Labs had a sample from Batch #730 Lot #K018 evaluated at an ISO/IEC accredited lab. Lead outcomes were 500 ppb (.5 ppm), which is within the legal limitations as defined by the State of Florida. Based on the test from the Florida Department of Agriculture and Consumer Services, 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 facility under the Florida Department of Food and Agriculture and Customer Services to produce products including CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement.
Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead direct exposure. To this date, Summitt Labs has not had a call, complaint or report of any adverse result from the usage of this product.
The product labels states that benefits may consist of, Anxiety Relief, Pain Decrease, State Of Mind Enhancer, Restful Sleep and might Reduce Stress. The item is packaged in 30 milliliter bottles; which might can be found in 9 count displays in Kraft paper product packaging. The impacted Kore Organic Watermelon CBD Oil lots consist of Batch #730 Lot #K018 The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30 milliliter bottle. The item was dispersed nationwide by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Worker, Tradeshow Samples, and by Summitt Labs.
Summitt Labs is alerting its suppliers and customers by email, phone, and personal visits to ensure the return of all recalled product. Customers, distributors and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being remembered, must stop utilizing the item.
Any customer with Lot #K018 Batch #730 in their belongings are urged to call 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 need to return this product to the location of purchase for a complete monetary refund. If that is rejected, please contact Summitt Labs at the above number for refund information and any other information regarding this recall. Consumers must call their physician or healthcare provider if they have experienced any problems that may be related to taking or utilizing this drug item. Media with any concerns 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 responses or quality issues experienced with the use of this product may be reported to the FDA’s MedWatch Unfavorable Event Reporting program either online, by routine mail or by fax.
- Complete 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 type, or submit by fax to 1-800- FDA-0178
- Side effects and negative responses dealing with 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.
Business Contact Information
- Sameer Jessani
- (404) 840-6337
- Christopher Cardamone, Esq
- (813) 842-7266