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ENTRINSIC HEALTH SOLUTION INC
FDA recall F-0999-2023 · Class II · reported 2023-06-28 · Terminated
- 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
- Reason
- Potential for the product to develop mold and spoil.
- Quantity
- 43,336 bottles
- Distribution
- 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
- Firm location
- MA, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Letter
- Recall started
- 2023-05-25
- Terminated
- 2024-03-22
- Code info
- 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
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.