Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 c
Summary
The FDA issued a Class I for Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, help by SUGARMDS LLC. Reason: MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide.
Details
Source
Drug Recall
External ID
D-0138-2024
Action Date
2023-12-13
Status
Ongoing
Category
drug
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.
Lot/Code Info: LOT# 22165-003, EXP 09/30/2024
Quantity Affected: 32,117
Reason for Recall
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Distribution
U.S. Nationwide and online websites.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-08
Company
Maryland Heights, MO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (SUGARMDS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUGARMDS LLC have FDA actions?
This is the only FDA action we have on record for SUGARMDS LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0138-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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