FDA (Drugs) recall action 85706
The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
The agency’s own wording, quoted from the enforcement report.
BIOTA Biosciences is recalling Sterile Curcumin 50mg/mL vials due to lack of assurance of sterility and the presence of unapproved ingredients.
Biota Biosciences is recalling sterile cannabidiol vials because they may not be sterile and were marketed without FDA approval.
BIOTA Biosciences is recalling sterile curcumin vials because the product lacks assurance of sterility and contains unapproved ingredients.
BIOTA Biosciences is recalling sterile Cannabidiol and Curcumin vials due to lack of sterility assurance and lack of FDA approval.
BIOTA Biosciences is recalling sterile Cannabidiol (CBD) vials due to lack of assurance of sterility and marketing without an approved NDA/ANDA.