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Health Resources : Recalls & Alerts

FDA Firm Recalls

Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling
Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.
Grande Produce Issues Voluntary Recall of Limited Quantity of Papaya “Caribeña” Due to Potential Health Risk
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
Hy-Vee, Inc. Issues Allergy Alert on Undeclared Soy in Hy-Vee Brand Pizzas
Hy-Vee, Inc. based in West Des Moines, Iowa, is voluntarily recalling eight Hy-Vee brand pizzas that were sold at its six Minneapolis-area stores because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA Investigates Multiple Salmonella Outbreak Strains Linked to Papayas
Please find more information about the Outbreak of Salmonellosis Linked to Papaya here:
Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance
Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of adverse events.
EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine
Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
The Idaho Foodbank Recalls Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product Because Of Possible Health Risk
The Idaho Foodbank is recalling approximately 27,000 pounds of Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product. These products are being recalled because they were not continuously maintained or stored at the required temperature due to a malfunction in the cooler. This could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed.
Bhu Foods Voluntarily Recalls Protein Bars for Possible Health Risk
Hudson Valley Foods, Inc. of Highland, NY has advised Bhu Foods of San Diego, CA that organic sunflower seeds sold to the company have been recalled. As a result of a recall of sunflower seeds from Hudson Valley Foods, Inc.,Bhu Foods’ supplier of organic sunflower seeds, advised Bhu Foods that ingredients sold to the company have the potential to be contaminated with Listeria monocytogenes.
Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil
Charlotte, NC, Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, [1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry], distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED).
Garden of Light Inc. Recalls Woodstock Organic Matcha Vanilla Oats Because of Possible Health Risk
Garden of Light, Inc. dba Gluten Free Solutions of East Hartford, CT, is voluntarily recalling the Woodstock Organic Matcha Vanilla Oats, 1.8 oz. which is manufactured by Garden of Light for Blue Marble Brands. The product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. The recalled item, Woodstock Organic Matcha Vanilla Oats, was distributed nationwide in retail stores.
Bestherbs Coffee LLC Issues Voluntary Nationwide Recall of New Kopi Jantan Tradisional Natural Herbs Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk
Grand Priarie, TX, Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). New of Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk.
Texas Legend Foods Issues Allergy Alert on Undeclared Cheese, Milk & Egg in "Silver Star Chipotle Dip"
Texas Legend Foods of Austin, TX, is recalling its 16 ounce jars of Silver Star Chipotle Queso Dip because they contain undeclared cheese, milk and eggs. People who have allergies to cheese, milk and eggs run the risk of a serious or life-threatening allergic reaction if they consume this product.
Sunneen Health Foods Issues Recall of Parfait Due to Undeclared Allergens
Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market PB&J parfaits sold at five Whole Foods Market stores in New York and New Jersey because the products contained soy and tree nut (almond and coconut) allergens that were not listed on the product label. People who have an allergy or severe sensitivity to soy or tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Andropharm Issues Voluntary Nationwide Recall of Sten Z and M1 Alpha Due to Labeling that it Contains Derivatives of Anabolic Steroids
lorida- Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.
Biohealth Nutrition Announces the Recall of Precision Blend Cookies and Cream Product for Undeclared Allergen
Biohealth Nutrition of San Dimas, CA is recalling Precision Blend Cookies & Cream because product labels failed to declare the food allergen, wheat. People who have an allergy or severe sensitivity to wheat run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume products containing allergens.
Coborn's, Inc. Issues Recall of Incorrectly Labeled Gluten Free Chocolate Chip Bars Due To Undeclared Milk
Coborn's, Inc. of St. Cloud, Minn. is recalling packages of its Gluten Free Chocolate Chip Bars, some of which were incorrectly labeled as Gluten Free Fudge Brownies. The Gluten Free Fudge Brownie label does not indicate the product contains milk, however the Gluten Free Chocolate Chip Bars that are incorrectly labeled as Gluten Free Fudge Brownies do contain milk.
Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables
During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.
Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks
Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.
Voluntary Recall of CLIF BUILDER'S Bar Chocolate Mint Flavor, CLIF Kid Zbar Protein Chocolate Mint and CLIF Kid Zbar Protein Chocolate Chip Flavors
Clif Bar & Company is initiating a voluntary recall of CLIF® BUILDER'S® Bar Chocolate Mint flavor, and CLIF Kid Zbar® Protein Chocolate Mint and CLIF Kid Zbar® Protein Chocolate Chip flavors due to possible presence of undeclared peanuts and some tree nuts, including almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, walnuts and coconuts. Clif Bar & Company is taking this precautionary safety step for people who are allergic to peanuts and these listed tree nuts. People with an allergy to peanuts and these specific tree nuts run the risk of a serious or life-threatening allergic reaction.
Hardcore Formulations Issues Voluntary Nationwide Recall of Ultra-Sten and D-Zine Capsules Due to Labeling that it Contains Anabolic Steroids
Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.

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FDA Consumer


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