The Recall Desk
SevereFDA (Drugs)·D-1330-2020·Announced 2020-07-01

BIOTA Biosciences Recalls Sterile Curcumin Vials Due to Sterility Concerns

BIOTA Biosciences is recalling Sterile Curcumin 50mg/mL vials due to lack of assurance of sterility and the presence of unapproved ingredients.

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 hazard involves a lack of assurance of sterility in a sterile product, which poses a risk of serious injury or death from infection.

Plain-English summary

BIOTA Biosciences LLC is recalling Sterile Curcumin 50mg/mL, 10 mL vials. The recall is due to a lack of assurance of sterility and because 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. The specific lot numbers involved are 071219CCD, 0712019CCD, and 07122019CCD, with an expiration date of 7/12/2021.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Sterile Curcumin 50mg/mL, 10 mL vial

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 #: 071219CCD
  • 0712019CCD
  • 07122019CCD
  • 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 →