Drug product
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
D-1329-2020
Product summary
- Event
- Event 85706
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1329-2020
Official wording
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Code information: Lot #: 101019PC, 1010019PC, 10102019PC, Exp. Date 10/10/2021
Distribution pattern: Nationwide within the United States and New Zealand
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility