BIOTA Biosciences Recalls Sterile Cannabidiol Vials for Sterility Concerns
BIOTA Biosciences is recalling sterile Cannabidiol (CBD) vials due to lack of assurance of sterility and marketing without an approved NDA/ANDA.
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 hazard involves a lack of assurance of sterility in a sterile product, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
BIOTA Biosciences LLC is recalling Sterile Cannabidiol (CBD) 4mg/mL, 10mL vials. The recall is due to a lack of assurance of sterility and the fact that the product 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 distributed nationwide within the United States and in New Zealand. Specific lot numbers involved in the recall are 2H071219P, 2H0712019P, and 2H07122019P, with an expiration date of 7/12/2021.
Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the point of purchase or disposed of according to local regulations for pharmaceutical products.
The recalled product
- Product
- Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
- Manufacturer
- BIOTA Biosciences LLC
- Category
- Drug — Sterile 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 #: 2H071219P
- 2H0712019P
- 2H07122019P
- Exp. Date 7/12/2021
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 and Curcumin Vials
FDA (Drugs) · 2020-07-01
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