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Class II: temporary or reversible health riskTerminated

BIOTA Biosciences Sterile Curcumin 50mg/mL Recall

Sterile Curcumin 50mg/mL, 10 mL vial

BIOTA Biosciences LLC · Seattle, WA

Risk level
Class II
Reported by FDA
Jul 1, 2020
Recall ID
D-1330-2020
Check your lot numberHow we source this data

Summary

BIOTA Biosciences recalled Sterile Curcumin 50mg/mL starting May 11, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1330-2020 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 Curcumin 50mg/mL, 10 mL vial

Lot numbers, UPCs & expiration codes

Lot #: 071219CCD, 0712019CCD, 07122019CCD, Exp. Date 7/12/2021

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-1330-2020
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-1330-2020, 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 #: 071219CCD, 0712019CCD, 07122019CCD, Exp. Date 7/12/2021
Postal code
98101-3603
Report date
Jul 1, 2020
Product type
Drugs
Recall number
D-1330-2020
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 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-1330-2020, 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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