FDA recall D-1327-2020

BIOTA Biosciences LLC · Class II · drug

Product

Sterile Curcumin, 4mg/mL, 10mL vial

Reason for recall

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

Distribution

Nationwide within the United States and New Zealand

Key facts

Status
Terminated
Initiation date
2020-05-11
Report date
2020-07-01
Termination date
2020-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Seattle, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1327-2020