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Class II: temporary or reversible health riskTerminated

BIOTA Biosciences Sterile Cannabidiol Recall

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

BIOTA Biosciences LLC · Seattle, WA

Risk level
Class II
Reported by FDA
Jul 1, 2020
Recall ID
D-1329-2020
Check your lot numberHow we source this data

Summary

BIOTA Biosciences recalled Sterile Cannabidiol starting May 11, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1329-2020 on Jul 1, 2020. Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 101019PC, 1010019PC, 10102019PC, Exp. Date 10/10/2021

Where it was sold

Nationwide within the United States and New Zealand

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1329-2020
Classification
Class II
Status
Terminated
Recall initiated
May 11, 2020
FDA report date
Jul 1, 2020
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
BIOTA Biosciences LLC

Original FDA data

Every field from FDA enforcement report D-1329-2020, exactly as published.

Show all FDA fields
City
Seattle
State
WA
Status
Terminated
Country
United States
Event ID
85706
Address
1601 5th Ave Ste 1100
Code information
Lot #: 101019PC, 1010019PC, 10102019PC, Exp. Date 10/10/2021
Postal code
98101-3603
Report date
Jul 1, 2020
Product type
Drugs
Recall number
D-1329-2020
Classification
Class II
Recalling firm
BIOTA Biosciences LLC
Termination date
Dec 3, 2020
Reason for recall
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Voluntary / mandated
Voluntary: Firm initiated
Product description
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Distribution pattern
Nationwide within the United States and New Zealand
Recall initiation date
May 11, 2020
Initial firm notification
E-Mail
Center classification date
Jun 19, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1329-2020, published Jul 1, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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