Products found to contain undeclared medicines
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| The United States: SugarMDs LLC issues voluntary nationwide recall of Advanced Glucose Support Supplement Capsules due to presence of undeclared glyburide and metformin |
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The US Food and Drug Administration (FDA) announces that SugarMDs, LLC is voluntarily recalling one lot of Advanced Glucose Support Supplement (lot number: 22165-003) in 60, 120 and 180 count bottles to the consumer level. 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 Supplement is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
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, SugarMDs LLC has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sugarmds-llc-issues-voluntary-nationwide-recall-advanced-glucose-support-supplements-capsules-due
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 4 Nov 2023.
Ends/Thursday, Nov 16, 2023
Issued at HKT 15:30
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