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Kingdom Honey Royal Honey VIP - recalled due to Undeclared Sildenafil, USA

2 months ago

United States

Shopaax.com in Newark, DE is voluntarily recalling all lots of Kingdom Honey Royal Honey VIP because it contains undeclared Sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. The use of products with the undeclared active ingredient may pose a threat to consumers because the active ingredient 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 these products, adult males who use nitrates for cardiac conditions are at the most at risk from these products.

The product comes in a golden box and contains 12 sachets of 20 grams of honey with different expiration dates stamped on the back side. It is promoted and sold for sexual enhancement on various websites, including www.shopaax.com and possibly in some retail stores. The product began selling on Shopaax.com on 02/2021 and was suspended on 07/2022.

The recall was initiated after FDA laboratory analysis confirmed that Kingdom Honey Royal Honey VIP contains Sildenafil, the active ingredient in the FDA-approved prescription drug Viagra. Selling of this product has been suspended on Shopaax.com and Shopaax.com has temporary removed all other products on the website pending investigation. The product may still be available on other websites and retail stores. Consumers who have purchased Kingdom Honey Royal Honey VIP on Shopaax.com are urged to immediately discontinue use and return recalled product 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 product.

Company name: Shopaax.com
Brand name: Kingdom Honey
Product recalled: Royal Honey
Reason of the recall: Undeclared Sildenafil
FDA Recall date: July 13, 2022

Source: fda.gov

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These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting... See More users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:
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- Magnetic denture attachments
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- Implantable ports and pumps (e.g., insulin pumps)
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- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy.

Patients should properly dispose of the mask that has magnets after an alternative is obtained. These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Impacted masks include: More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

Patients may contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice. This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.

In case you experienced 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.

Company name: Royal Philips’ subsidiary Philips Respironics
Brand name: Philips
Product recalled: Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps
Reason of the recall: potential risk of serious injury

Source: fda.gov
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Spot and Tango announced the recall of 4 batches of their Chicken and Brown Rice UnKibble Dog Food because samples tested positive for Salmonella bacteria.

The recalled product is Chicken and Brown Rice UnKibble Dog Food, with the codes:
-Lot Code T-22220 and SKU Number U-C-004
-... See More Lot Code T-22223 and SKU Number U-C-005
- Lot Code T-22220 and SKU Number U-C-006
- Lot Code T-22228 and SKU Number U-C-003

No other Spot & Tango products are affected by this recall.

Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Dogs with Salmonella infections will most likely not exhibit any symptoms, though in rare cases they may be lethargic and have diarrhea (which may be bloody), fever, and vomiting. Some dogs may have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy dogs can be carriers and infect other animals or humans through the fecal-oral route.

If you have the recalled product in your home, please stop feeding it to your dogs and dispose of it immediately.

Source: dogfoodadvisor.com
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Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501, expiry 09/24, packaged in 10-count blisters co-packaged in a carton and in 60-count bottles to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis has found... See More the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Wonder Pill capsules makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.

Consumers with underlying medical issues who take the Wonder Pill with undeclared 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, Proper Trade LLC/ My Stellar Lifestyle has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton, ASIN B0B6CWC9NK, and packaged in a 60-count bottle. The affected lots include lot numbers’ 20210912 & 31853-501, Expiry 09/24. The product can be identified by the labels below. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com and Walmart at www.walmart.com, nationwide in the USA.

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.

Proper Trade LLC/ My Stellar Lifestyle is notifying its customers by this press announcement and sending Amazon & Walmart messages to its customers and is arranging for return of all recalled products. Consumers that have Wonder Pill capsules which is being recalled should stop using the product.

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. 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Proper Trade LLC/My Stellar Lifestyle
Brand name: My Stellar Lifestyle
Product recalled: Wonder Pill Capsules
Reason of the recall: Product contains undeclared tadalafil
FDA Recall date: September 28, 2022

Source: fda.gov
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In case you experienced 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.

Company name: Eugia US LLC
Brand name: Auromedics
Product recalled: Acyclovir Intravenous Product
Reason of the recall: Presence of a dark red, brown and black particulate inside the vial
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