Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Shoppers-Plaza, a health supplement company based in Los Angeles, has voluntarily recalled all lots of its Fouzee Sugarlin Herbal Formula capsules due to the presence of undeclared prescription drugs Metformin and Glyburide, both of which pose serious health risks. The recall affects the herbal dietary supplement marketed as a glucose or blood sugar support product.
According to the company, the affected product contains Metformin, a prescription drug commonly used to treat type 2 diabetes, and Glyburide, another diabetes medication. Both of these substances can have dangerous side effects, particularly when taken by individuals who are unaware they are consuming them.
Metformin is linked to a potentially life-threatening condition called lactic acidosis, a build-up of lactic acid in the blood that can cause nausea, vomiting, abdominal pain, and respiratory distress, potentially leading to death if untreated. Glyburide, meanwhile, can cause dangerously low blood sugar levels (hypoglycemia), which may result in symptoms such as dizziness, confusion, seizures, or even coma in severe cases.
The recall affects the Fouzee Sugarlin Herbal Formula packaged in white bottles containing 180 vegetable capsules, with a UPC code of 26656690477. The product was sold nationwide through various online platforms, including Shoppers-Plaza’s official website and possibly in some retail stores.
Shoppers-Plaza has notified distributors and customers of the recall via email, their website, and social media. The company is offering full refunds to all consumers who return the product, which must be done through the platform where the product was purchased. Consumers who have used the product are urged to contact their healthcare provider to discuss any health concerns.
“We deeply regret the inconvenience this may cause our customers and are taking immediate action to remove all affected products from the market,” said the company in a statement. “We are committed to consumer safety and are working closely with regulatory authorities to ensure proper compliance.”
The U.S. Food and Drug Administration (FDA) is aware of the recall and has stated that the product was sold as an unapproved new drug, as its safety and efficacy have not been established.
Consumers, distributors, and retailers who possess any of the recalled units are urged to stop using the product immediately and return it to the point of purchase. For further information or to report adverse reactions, consumers can contact BICO Legal and Compliance Consulting at 786-796-6708 or email info@bicolegalcompliance.com.
For more details on how to report any issues, consumers can also visit the FDA’s MedWatch Adverse Event Reporting program.
