FDA recall F-0299-2024

Product

Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recommended Use: Thaw before use. Feed 0.5 milliliters a day to restore the infant gut microbiome. For sure under medical supervision. Ingredients: Medium chain triglucerides (MCT) oil, Bifidobacterium longum subsp. infantins EVC001 (milk, soy) CFU Count: 8 Billion CFU per 0.5 milliliters Manufactured For: Infinant Health Davis, CA 95618 customerservice@evivo.com

Reason for recall

Unapproved food additive.

Distribution

U.S. Distribution to the following: TX, OR, WA, AR, AL, NJ, IL, CA, FL, MN, HI, NY, NV, and AR No foreign distribution.

Key facts

Status

Terminated

Initiation date

2023-09-27

Report date

2023-10-18

Termination date

2024-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davis, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0299-2024