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Supplement

Updated: October 15, 2021 11:35 PM
The FSAI announced the recall of certain batches of Emergen-C Energy Release and Immunity Support Food Supplement due to the presence of the unauthorized pesticide ethylene oxide. Ethylene oxide is a pesticide that is not permitted for use in foods sold in the EU but is approved... See More for use by other countries outside the EU.

The recalled products are:
- Emergen-C Energy Release & Immunity Support Super Orange, Mega Pack 24 sachets, Lot # FUB03, Best before 01/24.
- Emergen-C Energy Release & Immunity Support Super Orange, Mega Pack 24 sachets, Lot # NT489, Best before 10/23.
- Emergen-C Energy Release & Immunity Support Super Orange, 8 sachets, Lot # GU393, Best before 10/23.

Although the consumption of the contaminated product does not pose an acute risk to health, there is an increased risk if there is continued consumption of contaminated food over a long period of time. Therefore, exposure to this substance needs to be minimised.

For more recall details check on FSAI website: fsai.ie

Source: FSAI
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The FSAI announced the recall of Aptonia sports food products by Decathlon due to the presence of the unauthorized pesticide ethylene oxide. Ethylene oxide is a pesticide that is not permitted for use in foods sold in the EU but is approved for use by other countries... See More outside the EU.

The recalled products are:
- Aptonia Vitamins and Minerals 30 tablets Orange flavour
- Aptonia salts caps 100 capsules
- Aptonia Electrolytes tablets Ecosize lemon flavour 2x20 tablets
- Aptonia Electrolytes tablets rasperry flavour 2x20 tablets
- Aptonia Electrolytes tablets lemon flavour 2x20 tablets

Although the consumption of the contaminated product does not pose an acute risk to health, there is an increased risk if there is continued consumption of contaminated food over a long period of time. Therefore, exposure to this substance needs to be minimized.

In case you are experiencing food poisoning symptoms, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance.

For more recall details check on FSAI website: fsai.ie

Source: FSAI
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Company name: NS NY Distributor Inc
Brand name: NS NY Distributor Inc
Product recalled: Premium Orgazen 7000 and Ginseng Power 5000 capsules
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 09, 2021
Recall details: Company Announcement NS NY Distributor Inc is voluntarily recalling... See More all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA  analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in Premium OrgaZen 7000 and Ginseng Power 5000 makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

Consumers with underlying medical issues who take Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or 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, NS NY Distributor Inc has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules. The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by amazon at www.amazon.com.

NS NY Distributor Inc is notifying customers who purchased through Amazon seller account Beauty.Kor by this press announcement. Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact NS NY Distributors Inc by email at NSNYdistributors@gmail.com.

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.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form 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.

Check the full recall details on fda.gov

Source: FDA
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Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cliffside Park, NJ, Yolo Studio is... See More voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 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, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.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.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. 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.
- Regular Mail or Fax: Download form 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.

Check the full recall details on fda.gov

Source: FDA
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Company name: QMART
Brand name: IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 05, 2021
Recall details: Company Announcement Elmwood Park,... See More NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or 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, QMART has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed via internet and fulfilled by amazon at www.amazon.com. 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.
Check the full recall details on fda.gov
Source: FDA
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FDA announced the recall of Organic Kudzu Root Herbal Supplement by Mountain Rose Herbs due to the potential to be contaminated with Salmonella. No illnesses have been reported linked to this recall to date.

FDA advises consumers to discard the recalled products or return them to the... See More place of purchase. The product was distributed to customers in the US; and British Columbia, Nova Scotia, Ontario, and Quebec, in Canada.

- Organic Kudzu Root Herbal Supplement. All sizes. Lot # #24247-X / #24247.

Check the full recall on the FDA website fda.gov

Source: FDA
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October 11, 2021 – Tuffy's Pet Foods is issuing a voluntary recall of approximately 1,600 cases of Pure Vita Salmon Entree Dog Food in a Tetrapak carton following notification from the product manufacturer of potentially elevated levels of Vitamin D. No illnesses or injuries have been reported... See More from consumers to date.

Consuming elevated levels of vitamin D in dog food can cause adverse reactions in dogs of all sizes, including symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. When ingested at excessive levels, vitamin D can lead to serious health issues in dogs including renal dysfunction. While no reports of illness or injury have been reported from consumers to date, Tuffy’s is acting out of an abundance of caution and is removing the specific lots of product listed below from distribution.

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0901101N1. Best By dates: 29 Jun 2023 / 1 Sep 2023.

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Consumers who purchased the Pure Vita Salmon Entrée dog food product subject to this voluntary recall (as identified above) are urged to return the product to their retailer for a full refund.

For consumer information or questions regarding this voluntary recall, please contact Tuffy’s Pet Foods, Inc. at (800) 525-9155 from Monday-Friday, 8:00am-5:00pm Central Time

Company name: Tuffy’s Pet Foods, Inc.
Brand name: Nutri Source
Product recalled: Pure Vita Salmon Entrée Dog Food
Reason of the recall: Elevated Levels of Vitamin D
FDA Recall date: October 12, 2021

Check the full recall details on fda.gov

Source: FDA
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The FSAI announced the recall of certain batches of Emergen-C Energy Release and Immunity Support Food Supplement due to the presence of the unauthorized pesticide ethylene oxide. Ethylene oxide is a pesticide that is not permitted for use in foods sold in the EU but is approved... See More for use by other countries outside the EU.

The recalled products are:
- Emergen-C Energy Release & Immunity Support Super Orange, Mega Pack 24 sachets, Lot # FUB03, Best before 01/24.
- Emergen-C Energy Release & Immunity Support Super Orange, Mega Pack 24 sachets, Lot # NT489, Best before 10/23.
- Emergen-C Energy Release & Immunity Support Super Orange, 8 sachets, Lot # GU393, Best before 10/23.

Although the consumption of the contaminated product does not pose an acute risk to health, there is an increased risk if there is continued consumption of contaminated food over a long period of time. Therefore, exposure to this substance needs to be minimised.

For more recall details check on FSAI website: fsai.ie

Source: FSAI
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Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. To date, Bayer... See More has no known reports of adverse events related to this recall.

Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow, and blood disorders that can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally.

The affected Lotrimin® and Tinactin® spray products are over-the-counter antifungal products, sold individually or in combo packs.

The impacted products are:
- Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
- Lotrimin® AF Athlete's Foot Liquid Spray
- Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
- Tinactin® Jock Itch (JI) Powder Spray
- Tinactin® Athlete’s Foot Deodorant Powder Spray
- Tinactin® Athlete’s Foot Powder Spray
- Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at the link below. There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada, and Mexico through a variety of retail channels.

Bayer is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products. Consumers who have the products that are being recalled should stop using them.

Check the full recall details on fda.gov

Company name: Bayer U.S. LLC
Brand name: Lotrimin® AF and Tinactin®
Product recalled: Over the Counter (OTC) antifungal spray products
Reason of the recall: Presence of benzene
FDA Recall date: October 01, 2021

Source: FDA
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