Seattle, WA, United States
BIOTA Biosciences LLC recalls
1 recall recorded since 2018, most recently on 11 May 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 11 May 2020
- Terminated
- 3 December 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1329-2020, D-1330-2020, D-1327-2020, D-1326-2020, D-1328-2020
- Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
- Sterile Curcumin 50mg/mL, 10 mL vial
- Sterile Curcumin, 4mg/mL, 10mL vial
- Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
- Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.