TOPIC: Advanced Glucose Support Capsules by SugarMD: Recall - Due to Presence of Undeclared Glyburide and Metformin
AUDIENCE: Consumer, Health Professional, Endocrinology
ISSUE: SugarMDs is recalling Lot: 22165-003 Advance Glucose Support Capsules in 60, 120 and 180 count bottles because FDA analysis has found the product to be tainted with glyburide and metformin. 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 Capsules are 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.
To date, SugarMD has not received any reports of adverse events related to this recall.
The product was distributed nationwide in the US -through internet sales via amazon.com and sugarmds.com.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The tainted Advanced Glucose Support Capsules are marketed as a dietary supplement.
RECOMMENDATIONS:
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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.
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Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase for a full refund.
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Consumers with questions regarding this recall can contact the company.
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