Class IIOngoing · reported 2023-05-31

TruBoost 7 Day Experience Kit

TruVision Health LLC recalled this product and the FDA reported the enforcement action on 31 May 2023 as Class II. The recall was initiated by the firm. The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product
TruBoost 7 Day Experience Kit
Reason for recall
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
Recalling firm
TruVision Health LLC
Firm location
Draper, Utah, United States
Classification
Class II
Status
Ongoing
Recall number
F-0949-2023
Quantity
14,510 packs
Distribution
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming and Australia, Canada, England, Germany, Ireland, New Zealand
Initiated
27 April 2023
Reported by FDA
31 May 2023
Firm notified by
Press Release
Product codes
Lot 13985

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
  • The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
  • This is one of 12 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 12 separate recalls, which almost every published figure does, overstates it by a factor of 12. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 12 of them.
  • This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
  • The FDA published the enforcement report 5 weeks after the firm began the recall.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Other records from TruVision Health LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 11 other records name this firm.

ReportedProductFirmReasonClass
2023-05-31truControl W/Dynamine 60 ctTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31TruWeight and Energy Gen 2+ 60 CountTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31reFORMTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31TruBoost Drink - Citrine SparkTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31TruBoost Drink - Ruby RevTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31Truvy 7-Day Experience KitTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31Truvy 30-Day Experience KitTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31TruControl 7 Day TrifoldTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31TruWeight and Energy Gen 2+ TrifoldTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II
2023-05-31Truvy Boost 30-Day Experience KitTruVision Health LLCThe products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.Class II

All 12 records for TruVision Health LLC

All 2023 recalls · All FDA food recall data

Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.