Biota Biosciences is back in the news. Last month they received a warning letter from the FDA for illegally marketing their CBD products, CBD Injectables, with claims that they can treat medical conditions such as opioid addiction.
The FDA said that the company was violating federal statutes both by engaging in interstate commerce of an unapproved new drug and failing to properly label the products by neglecting to include directions for use.
This time the company is issuing a voluntary nationwide recall of their CBD products, Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables because they were marketed without FDA approval.
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.Statement posted on the FDA’s website
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.
The company released a public response published on May 15th telling consumers that “as a valued customer with confirmed receipt of one of these products, we would like to convey that the executive and management team at Biota Biosciences take full responsibility for these observations and understand the gravity of the risk to consumers by posting these unapproved claims and intended use on our website. We extend our sincerest apologies for having exposed you to such risk.”
Consumers with questions regarding this recall can contact Biota Biosciences by phone number at (866) 996-2293 Monday to Friday from 8:00 am to 4:00 pm PST or by e-mail at firstname.lastname@example.org.
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.
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.