Haute Health, LLC is voluntarily recalling all lots of Virilis Pro, PHUK and Prolifta at the retail and consumer level. Virilis Pro, PHUK and Prolifta have been found to contain amounts of the PDE-5 Inhibitor sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction (ED).
Big Blue Fisheries is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
CareFusion issued the following update regarding its previously announced voluntary recall of AVEA® ventilators. The company initiated the voluntary recall on Sept. 3, 2013
On September 27, 2013, Afikim Electric Vehicles initiated a nationwide recall of 69 Breeze C Scooters. The Breeze C Scooter may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion
Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products may be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems.
A limited number of P.F. Chang’s Home Menu Pork and Leek Dumpling frozen appetizer sold at retail in 12.5 ounce bags is being recalled due to the possible presence of undeclared allergens, crustacean shellfish (shrimp) and fish (pollock). There have been no reported cases of illness. This recall does not affect any P.F. Chang’s restaurants.
Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
Semifreddi’s Inc. of Alameda, CA is recalling all packaged Almond Biscotti and Chocolate Dipped Almond Biscotti because the food allergens milk and soy were not declared on the product labels. People who have an allergy or severe sensitivity to milk or soy run the risk of serious allergic reaction, including anaphylaxis, if they consume the products.
HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA) event, if needed.
Wegmans is recalling 4,327 units of Wegmans brand APPLE CINNAMON Mini Muffins, Net Wt. 14 oz., because the product contains undeclared soy. People who have an allergy to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Myerstown, PA – September 12, 2013 – As a result of an internal review, Dutch Valley is issuing a recall on Honey Roasted Peanuts due to undeclared Milk and Wheat Ingredients. Individuals with food allergies to Milk and or Wheat may run the risk of a serious or life threatening allergic reaction if they consume these products.
Hospira, Inc. (NYSE: HSP), announced today, on July 12, 2013, it initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02).
Schwebel Baking Company today recalled 18,979 units of Golden Rich Buns with Honey due to mislabeling and undeclared egg. Through the package validation process the problem was discovered.
Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA). DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
nding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter’s Compounding Pharmacy’s independent testing laboratory. The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
Talenti® Gelato & Sorbetto is voluntarily initiating a product recall of Talenti German Chocolate Cake Gelato pints with the UPC # 1 8685200063 1 with a BEST BY DATE of 11/04/2014 M1, 11/24/2014 M1, and 11/24/2014 M2 as a precautionary measure. The recall was initiated after it was discovered by the firm that the product may contain undeclared almonds.
Bubbles Baking Co. is voluntarily recalling 9,229 cases of Blueberry Muffin 14 oz and Blueberry Loaf Cake 16 oz. due to undeclared milk and soy allergen. People who have allergies to milk and soy run the risk of serious or life-threatening reactions if they consume these products
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications. The recall is a result of concerns of sterility assurance with the specialty pharmacy‘s independent testing laboratory, Front Range Laboratories.
Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials, to the consumer level.
General Mills announced today a voluntary Class II recall of a limited quantity of refrigerated Pillsbury Cinnamon Rolls with Icing. No other flavors or varieties of Pillsbury Cinnamon Rolls or Pillsbury dough products are being recalled.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“McNeil”) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (see full product list below). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Chobani, Inc., of Twin Falls, Idaho is voluntarily recalling Greek Yogurt. The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.
GoPicnic Brands, Inc. is voluntarily recalling two vegan ready-‐to-‐ eat meals, GoPicnic Black Bean Dip & Plantain Chips and Hummus & Crackers, containing Professor Zim Zam’s Extraordinary Sweets Dark Chocolate with Orange and Dark Chocolate with Sea Salt. The chocolate products in these meals may contain an undeclared milk allergen.
University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from
Aqueboque, NY, Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so
Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table) due to our inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients. Though Medaus received test results indicating that these lots met all safety standards, they are being recalled because the independent testing lab’s sterility testing practices as applied to these lots indicate that the product’s sterility cannot be confirmed
Cains Foods is recalling 2,273 six-pack cases of 16 oz. Olde Cape Cod Chipotle Ranch dressing with a “Best By” date of Nov. 30, 2014 because it may contain undeclared milk and egg. People who have allergies to milk and egg run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
Garden-Fresh Foods, Inc. of Milwaukee Wisconsin is recalling A Limited Quantity of Spartan Fresh Selections American Potato Salad In 16 oz. Packages, because it 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.
Hospira, Inc. announced today it is initiating a voluntary nationwide user-level recall of one lot of Aminosyn II 10 percent, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure.
Premier Foods, LLC of Santa Fe Springs, CA is voluntarily recalling four flavored sauces due to the failure to declare the following allergens on the product labels: milk, soy, and/or wheat. The products were sold at Williams-Sonoma. People who have allergies to milk, soy, and/or wheat run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
St. Louis, Missouri, Nestle Purina PetCare Company (NPPC) is voluntarily recalling a limited number of 3.5-pound bags of its Purina ONE beyOnd Our White Meat Chicken and Whole Barley Recipe Adult Dry Dog Food from a single production run and shipped to retail customers in the United States. This is being done because one bag of the product was found to be contaminated with Salmonella.
FRUIT TREASURE of CHULA VISTA, CA is recalling 43 boxes (25lb) of fresh THAI PEPPERS, because it has the potential to be contaminated with Salmonella, an organism which 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 (which may be bloody), nausea, vomiting and abdominal pain.
Lowlite Investments d/b/a Olympia Pharmacy (“Lowlite”) today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance.
Today, Lightlife Foods in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of its Lightlife Farmer’s Market Veggie Burgers that may contain an undeclared allergen, milk. Certain packages of the Farmer’s Market Veggie Burgers may have inadvertently been filled with Lightlife Kick Black Bean Burgers, which contain an allergen, milk. The milk allergen is not declared on the Farmer’s Market Veggie Burger product label. This product was shipped to food stores and distributors nationwide.
Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free.
Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 lb. bag, CM25SCON Basic Scone Mix 25 lb. Bag, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Galveston Shrimp Company has issued a precautionary voluntary recall of its pre-packaged Texas Gulf Shrimp due to foreign material found in a bag. The pre-packaged bags are shipped to HEB Stores. Customers who recently purchased pre-packaged Gulf Shrimp are encouraged to check their refrigerators and/or freezers.
May 10, 2013 – Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013.
Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy to milk and/or walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level. The recall resulted from a recent inspection conducted by the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy where visible particulates (filaments) were observed in vials of sterile compounded products: TRIMIX, BIMIX (Lot 02252013@3), ALPROSTADIL, DMSO 50 PERCENT – IRRIGATION (Lot 03122013@19), and BACTERIOSTATIC WATER FOR INJECTION (Lot 01072013@28).
La Preferida, Inc. is voluntarily recalling 4,734 cases (56,808 cans) of La Preferida Whole Pinto Beans 29 oz. (Water & Salt). Can Code: PINTO LP, BEST BY 01/03/2015, “Time” 3003. The manufacturer’s preliminary inspection indicates 420 cans may not have been fully processed, which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed.
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