- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionUnapproved new drug
- Company Name:
- Biota Biosciences, LLC
- Brand Name:
Brand Name(s)Biota Biosciences
- Product Description:
Product DescriptionCannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin
Seattle, Washington, Biota Biosciences is voluntarily recalling the following lots in the table below of Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex, Sterile Curcumin previously listed as Curcumin Complex, Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex 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.
|Multiple Dose Vial Size||Lot||Expiration|
|Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex||4||10 mL||2H071219P
|Sterile Curcumin previously listed as Curcumin Complex 4 10 mL 2H071219CCD 2H0712019CCD 2H07122019CCD 07/12/2021||4||10 mL||2H071219CCD
|Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex||50||10 mL||101019PC
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.
Water Soluble (4mg/mL) 10mL products can be identified by the following labels: (see below)
Water Soluble (50mg/mL) 10mL products can be identified by the following labels: (see below)
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 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.
- Complete and submit the report Online
- 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- (866) 996-2293
- Ben Sinclair
- (866) 996-2293