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Dietary Supplements

Recalls & Warnings

07/28/2020 – FDA Recall for Watermelon CBD Oil for high lead levels; 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. 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.

09/30/2019 – FDA Recall for unsafe levels of arsenic and lead in Multimineral and Vitamin Supplement Powder Mix; Port Jefferson Station, NY, Cellect Products Inc. and Oglethorpe Ltd. are voluntarily recalling lot #041907 of Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder (1.25 LB) to the retail and consumer level. The Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder has been found to have unsafe levels of Arsenic and Lead. The product is used as a supplement and is packaged in a white plastic bottle.The affected Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder has the following lot #041907 and a manufactured (MFG) date of 05/20/2019 stamped on the bottom. The product can be identified as a Multi-Mineral & Vitamin Supplement. The Cellect Unflavored Powder & the Essentials Factor Cell Synergy Unflavored Powder are distributed via retail and the internet to the USA and to individual customers in Canada, United Kingdom, Netherlands, Switzerland, France, Croatia, Romania, Russia, Australia, New Zealand, South Korea, Singapore, China, India, Thailand, and Japan.

Resources

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/summitt-labs-issues-voluntary-nationwide-recall-kore-organic-watermelon-cbd-oil-due-high-lead

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cellect-products-inc-and-oglethorpe-ltd-issue-voluntary-worldwide-recall-cellect-unflavored-powder