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.
What this means for you
Illness, injury, or structural failure has been reported. 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 →- SevereBIOTA Biosciences Recalls Sterile Curcumin Vials Due to Sterility Concerns
FDA (Drugs) · 2020-07-01
- SevereBiota Biosciences Recalls Sterile Cannabidiol Vials Due to Sterility Concerns
FDA (Drugs) · 2020-07-01
- SevereBIOTA Biosciences Recalls Sterile Curcumin Vials Due to Sterility Concerns
FDA (Drugs) · 2020-07-01
- SevereBIOTA Biosciences Recalls Sterile Cannabidiol Vials for Sterility Concerns
FDA (Drugs) · 2020-07-01
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