Multi-event May 2020 FDA Recall Drug by Biota Biosciences Llc
This Multi-event Class II drug recall was voluntarily initiated by Biota Biosciences Llc on May 11, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility and marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1328-2020
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
05-11-2020
07-01-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BIOTA Biosciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States and New Zealand
12-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Batch or Lot Expiration Information
Lot# : 101019P, 1010019P,10102019P, Exp. Date 10/10/2021
Recall Number: D-1326-2020
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
05-11-2020
07-01-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BIOTA Biosciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States and New Zealand
12-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Batch or Lot Expiration Information
Lot# : 2H071219P, 2H0712019P, 2H07122019P, Exp. Date 7/12/2021
Recall Number: D-1330-2020
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
05-11-2020
07-01-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BIOTA Biosciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States and New Zealand
12-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Curcumin 50mg/mL, 10 mL vial
Batch or Lot Expiration Information
Lot# : 071219CCD, 0712019CCD, 07122019CCD, Exp. Date 7/12/2021
Recall Number: D-1327-2020
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
05-11-2020
07-01-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BIOTA Biosciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States and New Zealand
12-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Curcumin, 4mg/mL, 10mL vial
Batch or Lot Expiration Information
Lot# : 2H071219CCD, 2H0712019CCD, 2H07122019CCD, Exp. Date 7/12/2021
Recall Number: D-1329-2020
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
05-11-2020
07-01-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BIOTA Biosciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States and New Zealand
12-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Batch or Lot Expiration Information
Lot# : 101019PC, 1010019PC, 10102019PC, Exp. Date 10/10/2021
