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Dr. Ergin’s SugarMD Advanced Glucose Support, Dietary Supplement - recalled due to undeclared Glyburide and Metformin, USA
2 weeks ago
United States
SugarMDs, LLC is voluntarily recalling Lot: 22165-003 Advance Glucose Support Supplement in 60, 120 and 180 count bottles to the consumer level. FDA analysis has found the product to be tainted with glyburide and metformin. The product was distributed Nationwide in the US -through internet sales via amazon and their website. To date, SugarMDs LLC has not received any reports of adverse events related to this recall.
Glyburide and Metformin are active ingredients found in several FDA-approved prescription drugs used to treat type 2 diabetes. Products containing glyburide and metformin cannot be marketed as dietary supplements. Advanced Glucose Support Supplement is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: 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. 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.
This tainted Advanced Glucose Support is marketed as a dietary supplement and is packaged in:
- 60 count bottle : UPC code 00195893927678 (UPC code located below the "Supplement Facts" panel)
- 120 count bottle: UPC code 00195893546978
- 180 count bottle: UPC code 00195893999576
An example product label can be found in the picture attached. The affected Advanced Glucose Support lots include the following: Lot# 22165-003 EXP: 09/2024
SugarMDs LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase for a full refund. 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: SugarMDs, LLC
Brand name: Dr. Ergin’s
Product recalled: SugarMD Advanced Glucose Support, Dietary Supplement
Reason of the recall: Undeclared Glyburide and Metformin
FDA Recall date: November 15, 2023
Source: fda.gov
288
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Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified... See More during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted. They were distributed nationwide to wholesalers across the US, beginning in January 2022 and September 2022, respectively. Novartis has not received any reports of adverse events related to this recall, to date.
Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Risk Statement: Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if overexposure continues.
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Novartis is notifying its distributors via a recall notification letter and is arranging for the return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is notifying healthcare providers who have prescribed this product to contact their patients. Consumers who have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their healthcare provider.
In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare provider.
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Company name: Novartis Pharmaceuticals Corporation
Brand name: Novartis
Product recalled: Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL
Reason for the recall: Due to crystallization formation
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- Product: TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder, NDC: 63736-532-05, Lot Code: 0B88345, Expiration: 02/24, Package Size: 4.5 oz/128 g
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Company name: Insight Pharmaceuticals
Brand name: TING®
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Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing. It was distributed to wholesale distributors and... See More specialty pharmacies nationwide between January 3, 2023, and February 13, 2023. To date, Bayer has not received any adverse events related to this recall.
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