Medications & Supplements/Dietary Supplements

BIOTA Biosciences LLC: Sterile CBD and Curcumin Vials Recalled for Sterility and Approval Issues

Agency Publication Date: June 19, 2020

Summary

BIOTA Biosciences LLC is recalling various 10mL sterile injectable vials containing Cannabidiol (CBD) and Curcumin. These products are being recalled because they lack assurance of sterility and were marketed without required FDA approval. The recall includes five different product formulations, including combined CBD and Curcumin vials, with expiration dates in July and October 2021. These products were distributed nationwide in the United States and in New Zealand.

Risk

Products that are intended to be sterile but lack proper sterility assurance pose a significant risk of serious infection to patients when administered. Additionally, these products contain CBD and Curcumin as active drug ingredients that have not been evaluated or approved by the FDA for safety or effectiveness.

What You Should Do

Check your medical supplies for 10mL vials of Sterile Cannabidiol (CBD), Sterile Curcumin, or a combination of both with expiration dates of 7/12/2021 or 10/10/2021.
Identify if your product is affected by matching the following lot numbers: 2H071219P, 2H0712019P, 2H07122019P, 2H071219CCD, 2H0712019CCD, 2H07122019CCD, 101019P, 1010019P, 10102019P, 101019PC, 1010019PC, 10102019PC, 071219CCD, 0712019CCD, or 07122019CCD.
Stop using these recalled products immediately and do not administer them.
Contact your healthcare provider or pharmacist for guidance if you have been using these products, especially if you have experienced any adverse health effects.
Return any unused vials to the place of purchase for a refund and contact BIOTA Biosciences LLC for further instructions.
For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare guidance and product refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial

Lot Numbers:

2H071219P (Exp. 7/12/2021)

2H0712019P (Exp. 7/12/2021)

2H07122019P (Exp. 7/12/2021)

Date Ranges: Expiration Date 7/12/2021

Product: Sterile Curcumin, 4mg/mL, 10mL vial

Lot Numbers:

2H071219CCD (Exp. 7/12/2021)

2H0712019CCD (Exp. 7/12/2021)

2H07122019CCD (Exp. 7/12/2021)

Date Ranges: Expiration Date 7/12/2021

Product: Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

Lot Numbers:

101019P (Exp. 10/10/2021)

1010019P (Exp. 10/10/2021)

10102019P (Exp. 10/10/2021)

Date Ranges: Expiration Date 10/10/2021

Product: Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

Lot Numbers:

101019PC (Exp. 10/10/2021)

1010019PC (Exp. 10/10/2021)

10102019PC (Exp. 10/10/2021)

Date Ranges: Expiration Date 10/10/2021

Product: Sterile Curcumin 50mg/mL, 10 mL vial

Lot Numbers:

071219CCD (Exp. 7/12/2021)

0712019CCD (Exp. 7/12/2021)

07122019CCD (Exp. 7/12/2021)

Date Ranges: Expiration Date 7/12/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85706

Status: Resolved

Manufacturer: BIOTA Biosciences LLC

Manufactured In: United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medical supplies for 10mL vials of Sterile Cannabidiol (CBD), Sterile Curcumin, or a combination of both with expiration dates of 7/12/2021 or 10/10/2021.

Identify if your product is affected by matching the following lot numbers: 2H071219P, 2H0712019P, 2H07122019P, 2H071219CCD, 2H0712019CCD, 2H07122019CCD, 101019P, 1010019P, 10102019P, 101019PC, 1010019PC, 10102019PC, 071219CCD, 0712019CCD, or 07122019CCD.

Stop using these recalled products immediately and do not administer them.

Contact your healthcare provider or pharmacist for guidance if you have been using these products, especially if you have experienced any adverse health effects.

Return any unused vials to the place of purchase for a refund and contact BIOTA Biosciences LLC for further instructions.

For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial

Lot Numbers:

2H071219P (Exp. 7/12/2021)

2H0712019P (Exp. 7/12/2021)

2H07122019P (Exp. 7/12/2021)

Date Ranges: Expiration Date 7/12/2021

Product: Sterile Curcumin, 4mg/mL, 10mL vial

Lot Numbers:

2H071219CCD (Exp. 7/12/2021)

2H0712019CCD (Exp. 7/12/2021)

2H07122019CCD (Exp. 7/12/2021)

Date Ranges: Expiration Date 7/12/2021

Product: Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

Lot Numbers:

101019P (Exp. 10/10/2021)

1010019P (Exp. 10/10/2021)

10102019P (Exp. 10/10/2021)

Date Ranges: Expiration Date 10/10/2021

Product: Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

Lot Numbers:

101019PC (Exp. 10/10/2021)

1010019PC (Exp. 10/10/2021)

10102019PC (Exp. 10/10/2021)

Date Ranges: Expiration Date 10/10/2021

Product: Sterile Curcumin 50mg/mL, 10 mL vial

Lot Numbers:

071219CCD (Exp. 7/12/2021)

0712019CCD (Exp. 7/12/2021)

07122019CCD (Exp. 7/12/2021)

Date Ranges: Expiration Date 7/12/2021