CBD Products Recalled Due to Mislabeling Issue, FDA Announces
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Biota Biosciences, a Seattle-based CBD oil manufacturer and distributor, is voluntarily recalling several of its products after receiving a warning letter from the US Food and Drug Administration (FDA) last month.
The recall affects the company’s Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables, after these products were marketed without FDA approval and found to be mislabeled.
The company’s product recall was amplified through official FDA channels on Wednesday, May 20.
Recall of unapproved and mislabeled drugs
Biota Biosciences was served a warning letter from the FDA on April 9, after the federal agency reviewed the Biota Biosciences’ website and discovered the company to be selling various unapproved injectables.
“Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and 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,” reads the warning letter.
These injectables were marketed on the company’s website as being intended for use in suppressing pain and as a therapeutic for a wider range of conditions, including epilepsy and neuropathic conditions. This makes the products meet the definition of a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and as the products have not been generally recognized as safe, they may not be legally sold without FDA approval.
As well as being unapproved drugs, the three injectable products concerned in this recall were also found to be misbranded under the FD&C Act, as their labelling did not include “adequate directions for use”.
Products were distributed in the USA and in New Zealand
Biota Biosciences has not received any reports of adverse events related to these products, but it is initiating the product recall in order to comply with federal rules.
In the company announcement, Biota Biosciences reported that products were distributed nationwide in the USA, and to one consignee based in New Zealand. Biota Biosciences is now notifying distributors and customers by email and making arrangements to return all of the products concerned in the recall. Consumers who have purchased these products are to stop using the product and return it to the location where it was bought.
Biota Biosciences can be reached for questions about the recall by phone at (866) 996-2293 between 8am-4pm PST, Monday to Friday, or by email at firstname.lastname@example.org.
Adverse reactions to these products can be reported to the FDA's MedWatch Adverse Event Reporting online, or through submitting a report form via regular mail or by fax. Consumers experiencing problems that may be related to these products are encouraged to contact their physician or healthcare provider.