Drug product
Sterile Curcumin, 4mg/mL, 10mL vial
D-1327-2020
Product summary
- Event
- Event 85706
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1327-2020
Official wording
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Code information: Lot #: 2H071219CCD, 2H0712019CCD, 2H07122019CCD, Exp. Date 7/12/2021
Distribution pattern: Nationwide within the United States and New Zealand
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility