StaffFDA Announces CBD Product Recalls from Biota Biosciences, KORE CBD
Biota Biosciences
Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The product’s claims on the company’s website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.
| Product Name | Strength(mg) (mg/mL) |
Multiple Dose Vial Size | Lot | Expiration |
|---|---|---|---|---|
| Cannabidiol(CBD) Complex | 4 | 10 mL | 2H071219P | 07/12/2021 |
| 50 | 10 mL | 10102019P | 10/10/2021 | |
| Curcumin Complex | 4 | 10 mL | 2H071219CCD | 07/12/2021 |
| 50 | 10 mL | 0712019CCD | 07/12/2021 | |
| Cannabidiol + Curcumin | 50 | 10 mL | 10102019PC | 10/10/2021 |
Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.
Cannabidiol (CBD) Complex was marketed to suppress pain and aid in the detoxification processes as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. Curcumin Complex was marketed as a potent anti-inflammatory and antioxidant that may also help improve symptoms of depression and arthritis. Cannabidiol + Curcumin was marketed as a more efficient therapeutic effect. The product was sold to certified practitioners who further administer to customers. The product is packaged in 10 mL sterile vials. Products were distributed Nationwide in the USA and one consignee in New Zealand.
Water Soluble 4mg/10m products can be identified by the labels below.
Water Soluble 50mg/10m products can be identified by the labels below.
Biota Biosciences is notifying its distributors and customers by email and is arranging for return of all recalled products. Practitioners or consumers that have a product which is being recalled should stop using the product and return to the place of purchase.
Consumers with questions regarding this recall can contact Biota Biosciences by phone number at (866) 996-2293 Monday to Friday 8:00 am to 4:00 pm PST or by e-mail at hq@biotacbd.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Summit Labs
Summitt Labs is voluntarily recalling Batch#730 Lot#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 Batch #730 Lot #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 Batch #730 Lot #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 Batch #730 Lot #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 state 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 Batch#730 Lot#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 products. Consumers, distributors, and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop using the product.
Any consumer with Lot #K018 Batch #730 in their possession are urged to contact Summitt Labs by phone at (833) 810-5673 Monday-Friday 8 a.m. to 5 p.m. EST, or through the website at www.Koreorganic.com. Any consumer with Lot #K018 Batch #730 should return this product to the place of purchase for a full monetary refund. If that is denied, please contact Summitt Labs at the above number for refund information and any other information regarding this recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Contact the FDA
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Side effects and adverse reactions dealing with high levels of lead can be seen at www.Floridahealth.gov
- This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
