REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: BIOTA Biosciences' Sterile CBD + Curcumin Vials Flagged for Sterility and Unapproved Drug Status
BIOTA Biosciences LLC initiated a Class II recall for its Sterile Cannabidiol (CBD) + Curcumin 50mg/mL vials due to sterility assurance failures and marketing an unapproved drug. This event, impacting US and New Zealand markets, underscores critical regulatory and quality control risks for procurement and regulatory teams. Companies must scrutinize suppliers of novel compounds like CBD for robust FDA compliance and manufacturing integrity to mitigate supply chain disruptions.
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