Drug Enforcement D-0138-2024

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

Status

Ongoing

Classification

Class I

Report Date

December 13, 2023

Termination Date

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Product Information

Product description
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.
Product quantity
32,117
Reason for recall
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Recall initiation reason
—
Initial firm notification
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Distribution pattern
U.S. Nationwide and online websites.

Location & Firm

Recalling firm
SUGARMDS LLC
Address
11470 Schenk Dr

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

Codes & Dates

Recall number
D-0138-2024
Event ID
93394
Recall initiation date
November 8, 2023
Center classification date
December 2, 2023
Code info
LOT# 22165-003, EXP 09/30/2024
More code info
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