FDA MedWatch - Fouzee Sugarlin Herbal Formula by Shoppers-Plaza

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TOPIC: Fouzee Sugarlin Herbal Formula by Shoppers-Plaza: Recall - Due to Presence of Undeclared Metformin and Glyburide

AUDIENCE: Consumer, Health Care Professional, Pharmacy, Endocrinology, Gastroenterology

ISSUE: Shoppers-Plaza is recalling all lots of Fouzee Sugarlin Herbal Formula capsules because it 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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled 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.

RECOMMENDATIONS: 

• Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

• 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.

• Consumers with questions regarding this recall can contact BICO Legal and Compliance Consulting, LLC at:

Attention: Anthony Robinson, Esq.
Tel: 786/796-6708
Email: info@bicolegalcompliance.com

• Shoppers-Plaza is notifying its distributors and customers by email, its website (https://shoppers-plaza.com/pages/recall-fouzee-sugarlin-notice), and social media and is arranging for return of all recalled products.

Health care professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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