Biota Biosciences announced the voluntary recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables due to the products being marketed without the approval of the Food and Drug Administration (FDA).
The recalled lots of these injectable products include the following:
- Cannabidiol (CBD) Complex
- 4mg/mL; 10mL vial; Lot Number: 2H071219P; Exp Date: 7/12/2021
- 50mg/mL; 10mL vial; Lot Number: 10102019P; Exp Date: 10/10/2021
- Curcumin Complex
- 4mg/mL; 10mL vial; Lot Number: 2H071219CCD; Exp Date: 7/12/2021
- 50mg/mL; 10mL vial; Lot Number: 0712019CCD; Exp Date: 7/12/2021
- Cannabidiol + Curcumin
- 50mg/mL; 10mL vial; Lot Number: 10102019PC; Exp Date: 10/10/2021
These unapproved products were marketed with the following claims:
- Cannabidiol (CBD) Complex: 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: to improve symptoms of depression and arthritis.
- Cannabidiol + Curcumin: “a more efficient” agent for managing the aforementioned disorders.
According to the FDA, the safety and efficacy of these recalled products have not been established and injection may pose serious and life-threatening health risks, such as septicemia or sepsis. The Company also misbranded its products with labeling that fails to provide adequate directions for use.
At this time, the Company has not received any adverse event reports related to this recall. Adverse reactions may be reported to the FDA’s MedWatch program. The Company is notifying its distributors and consumers by email regarding the return of all recalled products. Practitioners or consumers in possession of the recalled product should discontinue use and immediately return the product to the place of purchase.
Consumers with questions regarding the recall can contact Biota Biosciences at (866) 996-2293 or via email at [email protected]
For more information visit fda.gov.