Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or Oral Administration Recommende
Summary
The FDA issued a Class II for Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For E by Infinant Health, LLC. Reason: Unapproved food additive..
Details
Source
Food Recall
External ID
F-0299-2024
Action Date
2023-10-18
Status
Terminated
Category
food
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/Code Info: Lot Number BES8042-11 BES8052-11 BES8062-11 BES8072-11 BES8082-11 BES8092-11 BES8013-11 BES8023-11 BES8033-11
Quantity Affected: 3,257 cartons
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-27
Company
Davis, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 14 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Infinant Health, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Infinant Health, LLC have FDA actions?
This is the only FDA action we have on record for Infinant Health, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0299-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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