D-1330-2020 Class II Terminated
FDA drug recall D-1330-2020 was initiated by BIOTA Biosciences LLC on May 11, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin The recall status is terminated (terminated December 3, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- May 11, 2020
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Sterile Curcumin 50mg/mL, 10 mL vial
Reason for Recall
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Distribution Pattern
Nationwide within the United States and New Zealand
Code Information
Lot #: 071219CCD, 0712019CCD, 07122019CCD, Exp. Date 7/12/2021