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