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Recall notice

Fouzee SugarLin Herbal Dietary Supplement recalled due to Metformin and Glyburide, USA

1 year ago source fda.gov

United States

Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall. 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.

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. 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). Hypoglycemia may quickly become severe, resulting in seizures, coma or death.

The recalled Fouzee SugarLin Herbal Formula is packaged in a white bottle containing 180 veg capsules, with UPC 26656690477. See Attachment for photo of product labeling,

Consumers, distributors, and retailers that have FOUZEE SUGARLIN HERBAL FORMULA must immediately stop using the product and return all units of the product in their possession to the place of purchase. A full refund will be provided on the same platform from which the product was purchased.

Company name: Shoppers-Plaza
Brand name: Fouzee
Product recalled: SugarLin Herbal Formula Herbal Dietary Supplement
Reason of the recall: Product contains undeclared Metformin and Glyburide
FDA Recall date: December 18, 2024

#drugs #recall #unitedstates

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