Biota Biosciences is voluntarily recalling multiple lots 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 products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.
The complete list of recalled products is available on the FDA website.
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.
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Biota Biosciences is notifying its distributors and customers by email and is arranging for return of all recalled products. Practitioners or consumers that have product which is being recalled should stop using product and return to 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.