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ENTRINSIC HEALTH SOLUTION INC Recall: Potential for the product to develop mold and spoil.

United States

TerminatedClass II

Company
ENTRINSIC HEALTH SOLUTION INC
Product
enterade Advanced Oncology Formula; Original Vanilla Flavor;…
Recall date
May 25, 2023
Terminated
March 22, 2024
Source
FDA

Reason for recall

Potential for the product to develop mold and spoil.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
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 Not published in this source record 43,336 bottles 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

  • 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

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0999-2023
Event ID
92408
Status
Terminated
Classification
Class II
Company
ENTRINSIC HEALTH SOLUTION INC
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
Quantity
43,336 bottles
Reason
Potential for the product to develop mold and spoil.
Recall initiation date
May 25, 2023
Report date
June 28, 2023
Classification date
Not published in this source record
Termination date
March 22, 2024
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
UPC, lot, and 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
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: ENTRINSIC HEALTH SOLUTION INC

Distribution map

A map highlighting the states named in the source's distribution description.

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map
State Distributed
Alabama 1
Arkansas 1
Arizona 1
California 1
Colorado 1
Connecticut 1
District of Columbia 1
Delaware 1
Florida 1
Georgia 1
Hawaii 1
Iowa 1
Idaho 1
Illinois 1
Indiana 1
Kansas 1
Kentucky 1
Louisiana 1
Massachusetts 1
Maryland 1
Maine 1
Michigan 1
Minnesota 1
Missouri 1
Mississippi 1
Montana 1
North Carolina 1
Nebraska 1
New Jersey 1
New Mexico 1
Nevada 1
New York 1
Ohio 1
Oklahoma 1
Oregon 1
Pennsylvania 1
Rhode Island 1
South Carolina 1
South Dakota 1
Tennessee 1
Texas 1
Utah 1
Virginia 1
Vermont 1
Washington 1
Wisconsin 1
West Virginia 1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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