enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL O
Summary
The FDA issued a Class II for enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps by ENTRINSIC HEALTH SOLUTION INC. Reason: Potential for the product to develop mold and spoil..
Details
Source
Food Recall
External ID
F-0999-2023
Action Date
2023-06-28
Status
Terminated
Category
food
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
Lot/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
Quantity Affected: 43,336 bottles
Reason for Recall
Potential for the product to develop mold and spoil.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-25
Company
Norwood, MA
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 17 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 (ENTRINSIC HEALTH SOLUTION INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ENTRINSIC HEALTH SOLUTION INC have FDA actions?
This is the only FDA action we have on record for ENTRINSIC HEALTH SOLUTION INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0999-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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