WASHINGTON (dpa-AFX) - Biota Biosciences recalled certain lots of pain suppressing medication Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin in the form of injectables as they were marketed without the approval of the U.S. Food and Drug Administration or FDA.
Biota Biosciences is a supplier and contract manufacturer of wholesale, private label, and white label CBD Hemp Oil products.
The company is recalling five lots of these three water soluble injectables that are packaged in 10 mL sterile vials in strengths of 40 mg and 500 mg, with expiration dates between July 12, 2021 and October 10, 2021.
The company said 'The products claims on our website make these products unapproved new drugs.' Further, the products are misbranded because the labelling does not provide adequate directions for use.
The company noted that the injection of these unapproved new drugs 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. This can lead to serious and life-threatening conditions such as septicemia or sepsis.
Biota Biosciences is yet to receive any adverse reports related to the recalled products.
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. Meanwhile, Cannabidiol + Curcumin was marketed as a more efficient therapeutic effect.
These products were distributed across the U.S. and were sold to certified practitioners who further administer to customers. There was also one consignee in New Zealand.
The company said it is arranging for return of the recalled product, and urged practitioners and consumers to stop using product and return to the sellers.
Copyright RTT News/dpa-AFX
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