RECALL FOUZEE SUGARLIN NOTICE
BICO Legal and Compliance Consulting, LLC
1001 Brickell Bay Drive, Suite 2700 #D6 | Miami, Florida 33131 info@bicolegalcompliance.com | Telephone: 786/796-6708
Licensed to practice law in the States of Colorado (active), the District of Columbia (active), Florida (active), Louisiana ( inactive and in good standing), Maryland (inactive and in good standing), and North Carolina (active).
Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide
Company Contact:
Anthony Robinson, Esq.
BICO Legal and Compliance Consulting, LLC 1001 Brickell Bay Drive, Suite 2700
Miami, FL 33131
FOR IMMEDIATE RELEASE – December 16, 2024 – Los Angeles, California - Shoppers- Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See Attachment 1 for photo of product labeling. 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.
The recalled Fouzee SugarLin Herbal Formula is packaged in a white bottle containing 180 veg
capsules, with UPC 826656690477. See Attachment 1 for photo of product labelling.
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 the return of all recalled products.
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. 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 Hours: Monday to Friday 9am – 5pm Est.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report Online: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
End
Attachment 1
Product Label
