FDA recall record

ENTRINSIC HEALTH SOLUTION enterade Advanced Oncology Formula recall — FDA F-0999-2023

Potential for the product to develop mold and spoil.

Class IIclassification
F-0999-2023official record ID
Jun 28, 2023report date

Recall record at a glance

Official recordF-0999-2023
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmENTRINSIC HEALTH SOLUTION Inc.
Report dateJun 28, 2023
Recall initiation dateMay 25, 2023
Quantity43,336 bottles
LocationNorwood, MA, United States

Official product description

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

Why the product was recalled

Potential for the product to develop mold and spoil.

Distribution information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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