The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1329-2020·Announced 2020-07-01

BIOTA Biosciences Recalls Sterile Cannabidiol and Curcumin Vials

BIOTA Biosciences is recalling sterile Cannabidiol and Curcumin vials due to lack of sterility assurance and lack of FDA approval.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the source explicitly states a 'Lack of Assurance of Sterility' for a sterile product, which meets the rubric criteria for a Severe rating due to significant injury risk.

Plain-English summary

BIOTA Biosciences LLC is recalling Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vials. The recall is being conducted because the product lacks assurance of sterility and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product contains unapproved Cannabidiol and Curcumin.

The affected product is identified by Lot numbers 101019PC, 1010019PC, and 10102019PC, with an expiration date of 10/10/2021. The product was distributed nationwide within the United States and in New Zealand.

Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Manufacturer
BIOTA Biosciences LLC
Category
Drug — Unapproved Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by BIOTA Biosciences LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · BIOTA Biosciences LLC

See all →

Same hazard · sterility

See all →

Similar recalls