Summary
The FDA issued a Class II for Truvy 7-Day Experience Kit by TruVision Health LLC. Reason: The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients..
Details
Source
Food Recall
External ID
F-0947-2023
Action Date
2023-05-31
Status
Ongoing
Category
food
Product Description
Truvy 7-Day Experience Kit
Lot/Code Info: Lot 41404
Quantity Affected: 13,581 packs
Reason for Recall
The products contain DMHA and/or hordenine which FDA has determined are not acceptable dietary ingredients.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-27
Company
Draper, UT
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 71 food recalls issued in the same week, part of 204 food-related FDA actions this month.
TruVision Health LLC has 12 FDA actions in our database, including 12 recalls.
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 (TruVision Health LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TruVision Health LLC have FDA actions?
TruVision Health LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0947-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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