Recalls / Class II
Class IID-1329-2020
Product
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
- Affected lot / code info
- Lot #: 101019PC, 1010019PC, 10102019PC, Exp. Date 10/10/2021
Why it was recalled
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Recalling firm
- Firm
- BIOTA Biosciences LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1601 5th Ave Ste 1100, N/A, Seattle, Washington 98101-3603
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States and New Zealand
Timeline
- Recall initiated
- 2020-05-11
- FDA classified
- 2020-06-19
- Posted by FDA
- 2020-07-01
- Terminated
- 2020-12-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1329-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.