Products found to contain undeclared medicines
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| The United States: Shoppers-Plaza issues voluntary nationwide recall of Fouzee Sugarlin Herbal Formula due to presence of undeclared metformin and glyburide |
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The United States Food and Drug Administration (FDA) announces that Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level because product contains undeclared metformin and glyburide. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Metformin is the active ingredient in several FDA-approved prescription drugs used to treat type 2 diabetes and is only available with a prescription. 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.
Glyburide is the active ingredient in some FDA-approved prescription drugs used to treat type 2 diabetes and is only available with a prescription. 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.
This product was promoted and sold nationwide as a glucose or blood sugar support supplement on various websites including, www.shoppers-plaza.com and possibly in some retail stores.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shoppers-plaza-issues-voluntary-nationwide-recall-fouzee-sugarlin-herbal-formula-due-presence
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 7 Dec 2024.
Ends/Thursday, Dec 19, 2024
Issued at HKT 14:30
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