Food recall

ENTRINSIC HEALTH SOLUTION INC recall: enterade Advanced Oncology Formula

ENTRINSIC HEALTH SOLUTION INC, of Norwood, MA, recalled enterade Advanced Oncology Formula. The FDA's reason: “Potential for the product to develop mold and spoil.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on May 25, 2023, and the FDA first listed it in its Enforcement Report of June 28, 2023. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Other germs or toxins (botulism, hepatitis A, mold...)

Status

Terminated

Closed March 22, 2024

The recall

Company
ENTRINSIC HEALTH SOLUTION INC (Norwood, MA)
Reason, in FDA's words
“Potential for the product to develop mold and spoil.”
Where it was sold
AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
92408

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0999-2023 Class II

    enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after opening; Ingredients: Water, amino acid blend (L-Valine, L-Aspartic Acid, L-Serine, L-Threonine, L-Tyrosine), natural flavor, sodium chloride, sodium citrate, potassium chloride, magnesium chloride, calcium chloride, stevia leaf extract; Manufactured in the USA for: Entrisnic Bioscience LLC

    Codes: Lot: OEV24122 and Exp: 8/29/24; Lot: OEV24222 and Exp: 8/30/24; Lot: OEV24322 and Exp: 8/31/24; Lot: OEV24422 and Exp: 9/1/24; Lot: OEV24522 and Exp: 9/2/24; Lot: OEV24922 and Exp: 9/6/24; Lot: OEV25022 and Exp: 9/7/24; Lot: OEV25122 and Exp: 9/8/24; Lot: OEV25222 and Exp: 9/9/24; Lot: OEV25522 and Exp: 9/12/24

    Quantity: 43,336 bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of June 28, 2023.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.