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MAC DADDY DIETARY SUPPLEMENTS - recalled due to undeclared Sildenafil & Tadalafil, USA
1 year ago
United States
ABC SALES 1 INC is voluntarily recalling MAC DADDY RED Capsules, Lot 1230004, Exp 03/30/2024 and MAC DADDY PURPLE Capsules, Lot 1230005, Exp 03/30/2024 to the consumer level. ABC Sales 1 Inc was informed by Amazon that laboratory analysis found MAC DADDY RED capsules to be tainted with sildenafil and tadalafil and MAC DADDY PURPLE capsules to be tainted with tadalafil. The products were distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.
Sildenafil and tadalafil are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in MAC DADDY capsules makes these products unapproved drugs for which the safety and efficacy have not been established and therefore, subject to recall.
Consumers with underlying medical issues who take MAC DADDY capsules, with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, ABC SALES 1 INC has not received any reports of adverse events related to this recall.
These products are marketed as dietary supplements for male sexual enhancement and are packaged in 10-count blisters packaged in a carton. The affected MAC DADDY RED packages include lot 1230004, Exp 03/30/2024, ASIN: B07TLDZLY2, UPC 742137605191 and MAC DADDY PURPLE packages include lot 1230005, Exp 03/30/2024, ASIN: B08Z63Z4QK, UPC 742137605764. The product can be identified by the labels attached. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Consumers that have MAC DADDY RED or PURPLE capsules which are being recalled should stop using.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. FDA Press announcement.
Company name: ABC SALES 1 INC
Brand name: MAC DADDY
Product recalled: MAC DADDY RED and PURPLE DIETARY SUPPLEMENTS
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: February 08, 2022
Check the full recall details on fda.gov
Source: FDA
289
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Baxter has identified that after one or more downstream occlusion alarms occur on the Novum IQ syringe pump, the pump may display an “Infusion Complete” alarm despite fluid remaining in the syringe. This could lead to an underdose and/or interruption of therapy. The difference between the remaining volume to be infused displayed on the pump and the volume left in the syringe is dependent on the number of occlusion alarms encountered during an infusion and the size of the syringe being used.
If a patient does not receive the intended dose of a prescribed medication, serious or critical adverse health consequences may occur. Potential health consequences are dependent on multiple patient-specific factors (such as disease state as well as age and weight of the patient involved, and the care area where they are treated), occlusion pressure settings, the number of occlusions that occurred, the size of the syringe used, and the therapy being delivered.
This Urgent Medical Device Correction applies to Novum IQ syringe infusion pump with product code 40800BAXUS. Baxter has contacted affected customers and is developing a software update to resolve the issue. Until the software update is available, customers can continue to use Novum IQ syringe infusion pumps with the following reinforced guidance provided by Baxter:
- As stated in the pump’s Operator’s Manual, users should choose the smallest compatible syringe size necessary to deliver the fluid or medication.
- Prior to beginning an infusion, users should ensure the downstream occlusion pressure setting is appropriate for the clinical scenario. Consistent with standard clinical practice, users should always check for clamped lines and other sources of downstream occlusion prior to and during therapy. Pressure setting selection guidelines and instructions for downstream occlusion resolution can be found in section 8.8 of the Operator’s Manual.
- Per standard clinical practice, users should continue to monitor the “Volume to be Infused” and the volume delivered while therapy is in progress. This is especially true after a downstream occlusion alarm has occurred. Users should also take note of the initial volume and compare it to the final volume in the syringe. If the total dose is not delivered upon the “Infusion Complete” alarm, users should reprogram the pump and deliver the remaining volume as necessary.
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: Baxter International, Inc.
Brand name: Baxter
Product recalled: Novum IQ syringe infusion pump.
Reason of the recall: Potential for an incomplete infusion following one or more downstream occlusion alarms.
FDA Recall date: November 30, 2023
Source: fda.gov See Less
289
Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new... See More drug for which safety and efficacy have not been established and, therefore, subject to recall. The product was distributed and sold online on Amazon under the ASINs: B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ. To date, Meta Herbal has not received any reports of adverse events related to this recall.
Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction.
Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister packs of one pill, with a UPC 645759993007 exp 1/2025. Each blister pack is sold individually and holds one capsule.
Meta Herbal is notifying its customers via Amazon and is arranging for refunds. All blister packs of Magnum XXL 9800 are affected by this recall. Consumers who have the recalled product should stop using it and contact Meta Herbal for return/refund instructions.
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: Meta Herbal
Brand name: Magnum
Product recalled: Magnum Male Sexual Enhancement XXL 9800 capsule
Reason of the recall: Undeclared Sildenafil
FDA Recall date: November 29, 2023
Source: fda.gov See Less
289
Novartis Sandimmune Oral Solution - recalled due to due to crystallization formation, USA
4 days ago
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.
The affected lot numbers and expiration dates are:
- FX001500 (expiration date 09/2024)
- FX001582 (expiration date 09/2024) NDC 0078-0110-22.
These lots were only distributed in the US.
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.
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: 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
FDA Recall date: November 27, 2023
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Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lots of the... See More product contained elevated levels of benzene. The affected lots were distributed nationwide in the United States through a limited number of retailers and online. To date, the Company has not received any serious adverse events related to this recall.
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TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder is packaged in green and white aerosol cans with Lot codes located on the bottom of the can.
Samples of the recalled lots below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.
Affected products:
- Product: TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder, NDC: 63736-532-05, Lot Code: 0H88645, Expiration: 07/24, Package Size: 4.5 oz/128 g
- 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
Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray marked with one of the lot codes.
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: Insight Pharmaceuticals
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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: Bayer
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Product recalled: Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles
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