Drug Enforcement D-0042-2025

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.

Status

Ongoing

Classification

Class II

Report Date

November 20, 2024

Termination Date

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Product Information

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
Product quantity
150
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States; additionally Canada, England, and Australia.

Location & Firm

Recalling firm
Trinity Gold Nutrition
Address
201 Tom Hall St, STE 2107

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0042-2025
Event ID
95587
Recall initiation date
November 6, 2024
Center classification date
November 12, 2024
Code info
Lot #: IN-030, Exp. Date: NOV 2027
More code info
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