Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, For
Summary
The FDA issued a Class II for Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold N by Trinity Gold Nutrition. Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone..
Details
Source
Drug Recall
External ID
D-0042-2025
Action Date
2024-11-20
Status
Ongoing
Category
drug
Product Description
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009
Lot/Code Info: Lot #: IN-030, Exp. Date: NOV 2027
Quantity Affected: 150
Reason for Recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Distribution
Nationwide within the United States; additionally Canada, England, and Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
Fort Mill, SC
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 38 drug recalls issued in the same week, part of 267 drug-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 (Trinity Gold Nutrition) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trinity Gold Nutrition have FDA actions?
This is the only FDA action we have on record for Trinity Gold Nutrition in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0042-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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