April 8

Category: 

Drug Recalls

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil

Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Black 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 Black 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 Black 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.

QMART Issues Voluntary Nationwide Recall of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 Due to Presence of Undeclared Sildenafil and/or Tadalafil

Elmwood Park, 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.

A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling

Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.

The product is used as a pain and fever reliever. The 100-count bottles labeled with NDC 50090-5350-0 are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Distribution likely occurred between 1/14/21 and 3/15/21 nationwide in the USA. Expiration dates are either 7/31/22 or 8/31/22. The affected bottles that should be returned contain a short Rx drug label that lacks the full OTC Drug Facts chart.

NANA Collection LLC Issues Voluntary Nationwide Recall of PremierZen Platinum 5000 & Triple SupremeZen Gold 3500 Due to Presence of Undeclared Drug Tadalafil and Sildenafil

NANA Collection LLC is voluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared Tadalafil and Triple SupremeZen 3500 to contain undeclared Tadalafil and Sildenafil. 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 Tadalafil and Sildenafil in PremierZen Platinum 5000 & Triple SupremeZen Gold 3500  renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Consumers with underlying medical issues who take PremierZen Platinum 5000 with Tadalafil and Triple SupremeZen Gold 3500 with undeclared Tadalafil and Sildenafil 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.

Nuri Trading LLC Issues Voluntary Nationwide Recall of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69, Due to the Presence of Undeclared Tadalafil, Sildenafil, and/ or Vardenafil

Nuri Trading is voluntarily recalling all lots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level. FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/or vardenafil. Sildenafil,tadalafil, and vardenafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.The presence of sildenafil, tadalafil, and/ or vardenafil in Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules make 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 Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69 capsules with undeclared sildenafil,tadalafil, and/or vardenafil 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.

Ummzy LLC Issues Voluntary Nationwide Recall of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night Due to the Presence of Undeclared Tadalafil Sildenafil & Vardenafil

Palisades Park, NJ, Ummzy LLC is voluntarily recalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules to consumer level. FDA analysis has found the product to contain undeclared tadalafil sildenafil & Vardenafil. Tadalafil, Sildenafil & Vardenafil are ingredients known as phosphodiesterase (PD-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.The presence of Tadalafil Sldenafil & Vardenafilin Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules 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 Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules with undeclared Tadalafil Sildenafil & Vardenafil 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.

Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine Fumarate

Weston, Florida, Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.

Food & Beverage Recalls

Glutenull Bakery Issues Allergy Alert on Undeclared Milk in Goji Berries and Chocolate Cookies

Glutenull Bakery of Port Coquitlam, BC, Canada is recalling Goji Berries and Chocolate Cookies 11oz/320g, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of allergic reaction if they consume this product.

Product was distributed in WA and OR in retail stores such as Whole Foods Market and Market of Choice.

The Glutenull Goji Berries and Chocolate Cookies product is packaged in clear plastic clamshell container with paper sleeve, net wt. 11 oz / 320g, and has the UPC 628451529132. The recalled product has all lots with the expiration dates 06/10/2021 to and including EXP 08/20/2021.

HI-TECH Pharmaceuticals Issues Allergy Alert on Various APS Isomorph 28 Products and iFORCE Nutrition Mass Gainz Dietary Supplements Due to Possible Undeclared Milk, Eggs, Wheat and Soy

Hi-Tech Pharmaceuticals. Inc. of Norcross, GA is recalling all lots of APS Nutrition Isomorph 28 flavors in a 2 lb jug because it contains undeclared milk, wheat & soy allergens. All lots of iForce Nutrition Mass Gainz Brown Sugar Maple Oatmeal Cookie in 4.85lb jugs and 10 lb bags is also being recalled because it contains undeclared eggs. People who have an allergy or severe sensitivity to specific type of allergen (milk, eggs, wheat & soy) run the risk of serious or life-threatening allergic reaction if they consume these products.

Rise Baking Company LLC Issues a Recall for Undeclared Hazelnut in Cakes

Rise Baking Company of York, PA is recalling its Harris Teeter Brand 8” 3-layer Cookies and Creme Cake and Dawn Food Products Brand 7” 2-layer Vanilla Bean Waterfall Cake due to incorrect allergen labeling on the product. The product label does not list Hazelnut, and Hazelnuts are present in the product. People who have an allergy or severe sensitivity to Hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume the product.

b.a. Sweeties Candy Co. Issues Voluntary Recall of its Chocolate Malt & Chocolate Malted Milk Balls

b.a. Sweetie Candy Co in Cleveland, Ohio is voluntarily recalling its Chocolate Malt Balls and Chocolate Malted Milk Balls due to an undeclared wheat allergen. This recall has been initiated due to the ingredient label not stating a wheat allergen.

Products were packaged in either a 4.5 oz clam pack container labeled “Chocolate Malt Balls” with a Dave’s Supermarket label or in bulk, packaged in a 3 lb bag, labeled “Chocolate Malted Milk Balls Bulk” with a b.a. Sweetie Candy Company label.

Products were available for sale at the following locations in Ohio:

  • Sweetie Candy Company retail store
  • All Dave’s Market Grocery Stores in Cleveland, Akron, Garfield Heights, Euclid, Cleveland Heights, and Richmond Heights
  • Groovy Candies, Cleveland
  • L&E Sugarbuzz, Amhurst