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Recall Observatory FDA recall evidence

Food product

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

F-0999-2023

May 25, 2023

Class II

Product summary

Firm
ENTRINSIC HEALTH SOLUTION INC
Event
Event 92408
Status
Terminated
Classification
Class II
Quantity
43,336 bottles
Official record key
food-enforcement:F-0999-2023

Official wording

Reason: Potential for the product to develop mold and spoil.

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the product to develop mold and spoil.