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Recall Observatory FDA recall evidence

Drug product

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.

D-0138-2024

November 08, 2023

Class I

Product summary

Firm
SUGARMDS LLC
Event
Event 93394
Status
Ongoing
Classification
Class I
Quantity
32,117
Official record key
drug-enforcement:D-0138-2024

Official wording

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

Code information: LOT# 22165-003, EXP 09/30/2024

Distribution pattern: U.S. Nationwide and online websites.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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