The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Krinos Foods, LLC. is Expanding its April 28, 2013 Recall to Include Additional Expiration Dates Jan 01-2014 to Jun 01-2014 of Tahini Products Because of Possible Health Risk
Krinos Foods, LLC. of Long Island City, New York is voluntarily recalling its TAHINI sesame paste, 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. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
FDA warns consumers about potential health risk with Juices Incorporated juice products
The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company’s carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.
FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
Dairy Fresh Conducts Voluntary Recall of IGA Brand “Vanilla & Chocolate” 1.75 Quart Ice Cream Because Package May Contain Undeclared Allergens (Almonds, Coconut, Soy)
Dairy Fresh is voluntarily recalling a specific batch of IGA Brand “Vanilla & Chocolate” Ice Cream (1.75 quart, 1.66L) with the plant code “3783” and a SELL BY date of 08-13-13 because it incorrectly contains Heavenly Hash ice cream, which contains almonds, coconut, and soy, which are allergens not declared on the carton. People who have an allergy or severe sensitivity to almonds, coconut, or soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Whole Foods Market Recalls Mislabeled Curried Chicken Salad and Vegan Chick’n Salad Sold at the Cold Salad Bar Due to Undeclared Allergens
May 9, 2013 – CAMBRIDGE, MA. – Whole Foods Market is recalling bulk curried chicken salad and bulk vegan curried chick’n salad because in some stores these items may have been sold with reversed labels causing undeclared soy and egg allergens. Due to the label mix-up, allergens were undeclared; the vegan chick’n salad contains soy, and the curried chicken salad contains egg.
Pure Herbs Ltd. Issues Allergy Recall Alert on Undeclared Allergens (Milk and Soy) in Protein Extract Urgent Undeclared Allergen Labeling Recall In Pure Herbs Ltd. Protein Extract
Today, Pure Herbs Ltd., Sterling Heights, MI is voluntarily recalling the 4oz and 1oz bottles of Protein Extract because they contain undeclared allergens – milk and soy. This labeling error was discovered during a routine Food and Drug Administration (FDA) inspection when a review of the ingredients found that milk and soy allergen ingredients were not listed on our main label.
Bimeda Inc. on Behalf of Manufacturer Bimeda-MTC Animal Health Inc. Issues Voluntary Nationwide Recall of Sterile Solutions Due to Concerns Regarding Sterility and Possible Health Risk
Bimeda Inc., on behalf of the manufacturer, Bimeda-MTC Animal Health Inc. is voluntarily recalling one lot of Calcium Gluconate, one lot of Dextrose 50%, and one lot of Hypertonic Saline, all of which are in the form of injectable fluids, to the user level. These injectable fluids are being recalled as a precautionary measure; because of departures from customary sterility procedures, sterility cannot be entirely assured.
FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
XYMOGEN identifies allergen oversight by third-party manufacturer; issues recall of artriphen™
Nutraceutical company XYMOGEN in Orlando, Fla., is recalling artriphen, a product recommended for the support of healthy joint function, because it contains traces of the undeclared allergens soy and milk.