Summary
- Company Announcement Date:
- July 28, 2020
- FDA Publish Date:
- July 28, 2020
- Product Type:
- Drugs
- Reason for Announcement:
-
Contains lead
- Company Name:
- Summitt Labs
- Brand Name:
-
KORE ORGANIC
- Product Description:
-
Watermelon CBD oil tincture
Company Announcement
UPDATED 7-28-20 TO CORRECT LOT# & BATCH# – Tampa, Florida; Summitt Labs is voluntarily recalling Lot #730 Batch #K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Lot #730 Batch #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Lot #730 Batch #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.
Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing 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 Lot #730 Batch #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product.
The product labels states that benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress. The product is packaged in 30 milliliter bottles; which could come in 9 count displays in Kraft paper packaging. The affected Kore Organic Watermelon CBD Oil lots include Lot #730 Batch #K018. The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30-milliliter bottle. The product was distributed nationwide 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 distributors and customers by email, phone, and personal visits to ensure the return of all recalled product. Consumers, distributors and retailers that have Kore Organic Watermelon CBD Oil Lot #730 Batch #K018, which is being recalled, should stop using the product.
Read the full FDA report here.
As published by HealthyExaminer.com
