United States
SugarMDs, LLC is voluntarily recalling Lot: 22165-003 Advance Glucose Support Supplement in 60, 120 and 180 count bottles to the consumer level. FDA analysis has found the product to be tainted with glyburide and metformin. The product was distributed Nationwide in the US -through internet sales via amazon and their website. To date, SugarMDs LLC has not received any reports of adverse events related to this recall.
Glyburide and Metformin are active ingredients found in several FDA-approved prescription drugs used to treat type 2 diabetes. Products containing glyburide and metformin cannot be marketed as dietary supplements. Advanced Glucose Support Supplement is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Glyburide may pose serious and potentially life-threatening risks to consumers because this ingredient may result in unsafe drops in blood sugar levels (hypoglycemia). Common symptoms of hypoglycemia include fast heartbeat, shaking, sweating, nervousness or anxiety, irritability or confusion, dizziness, drowsiness, headache and hunger. Hypoglycemia may quickly become severe, resulting in seizures, coma or death. Metformin may pose a serious risk to consumers because this ingredient can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated. Symptoms of lactic acidosis include nausea, vomiting, fatigue, body aches, respiratory distress, abdominal pain and fast, deep breathing. Metformin may also cause hypoglycemia when taken together with other medications to lower blood sugar.
This tainted Advanced Glucose Support is marketed as a dietary supplement and is packaged in:
- 60 count bottle : UPC code 00195893927678 (UPC code located below the "Supplement Facts" panel)
- 120 count bottle: UPC code 00195893546978
- 180 count bottle: UPC code 00195893999576
An example product label can be found in the picture attached. The affected Advanced Glucose Support lots include the following: Lot# 22165-003 EXP: 09/2024
SugarMDs LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase for a full refund. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: SugarMDs, LLC
Brand name: Dr. Ergin’s
Product recalled: SugarMD Advanced Glucose Support, Dietary Supplement
Reason of the recall: Undeclared Glyburide and Metformin
FDA Recall date: November 15, 2023
Source:
www.fda.gov
