Drug & medication recalls Moderate risk

Sterile Cannabidiol + Curcumin 50mg/mL recalled over sterility concerns

Recall date
May 11, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
BIOTA Biosciences LLC recalls Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Recall number
D-1329-2020
FDA classification
Class II
Brand / firm
BIOTA Biosciences LLC
Sold / distributed
Nationwide within the United States and New Zealand

Why it was recalled

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

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