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Class II: temporary or reversible health riskTerminated

Infinant Health Evivo with MCT Oil Infant Probiotic Recall

Evivo with MCT Oil Infant Probiotic Activated B

Infinant Health, LLC · Davis, CA

Risk level
Class II
Reported by FDA
Oct 18, 2023
Recall ID
F-0299-2024
Check your lot numberHow we source this data

Summary

Infinant Health recalled Evivo with MCT Oil Infant Probiotic starting Sep 27, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0299-2024 on Oct 18, 2023. Reason: Unapproved food additive. Status: Terminated.

Why it was recalled

Unapproved food additive.

Product description

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

Lot numbers, UPCs & expiration codes

Lot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0299-2024
Classification
Class II
Status
Terminated
Recall initiated
Sep 27, 2023
FDA report date
Oct 18, 2023
Quantity
3,257 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Infinant Health, LLC

Original FDA data

Every field from FDA enforcement report F-0299-2024, exactly as published.

Show all FDA fields
City
Davis
State
CA
Status
Terminated
Country
United States
Event ID
93136
Address
2121 2nd St Ste B107
Code information
Lot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11
Postal code
95618-6567
Report date
Oct 18, 2023
Product type
Food
Recall number
F-0299-2024
Classification
Class II
Recalling firm
Infinant Health, LLC
Product quantity
3,257 cartons
Termination date
Sep 10, 2024
Reason for recall
Unapproved food additive.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
U.S. Distribution to the following: TX, OR, WA, AR, AL, NJ, IL, CA, FL, MN, HI, NY, NV, and AR No foreign distribution.
Recall initiation date
Sep 27, 2023
Initial firm notification
Letter
Center classification date
Oct 24, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0299-2024, published Oct 18, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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