Baxter International Inc. is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the high-risk patient population – patients prone to severe electrolyte imbalance – this hazardous situation may lead to serious, life-threatening adverse health consequences
Evershing International Trading Issues Allergy Alert on Undeclared Milk in Vinacafe Brand Coffee – Wake Up Weasel Instant Coffee mix 3-in-1
Evershing International Trading is voluntarily recalling Vinacafe Brand Wake Up Weasel Instant Coffee mix 3-in-1 after learning that the product may contain Sodium Caseinate ( a Milk derivative), a Milk allergen, and Soy extract, a Soy Allergen, that is not declared on the products’ ingredient statement. People who have an allergy or severe sensitivity to Milk and/or Soy have the risk of serious or life-threatening allergic reaction if they consume this coffee.
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FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
REFA Enterprises, LLC Issues Voluntary Nationwide Recall of Forever Beautiful Bee Pollen Due to Undeclared Sibutramine and Phenolphthalein
REFA Enterprises, LLC is voluntarily recalling one lot of each: Forever Beautiful Bee Pollen (UPC # 6333090804632), Forever Beautiful Infinity UPC # 633090804649), to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.
Lundberg Family Farms Recalls Eco-Farmed and Organic Brown Rice Flour Because of Possible Health Risk
Lundberg Family Farms announced that it is voluntarily recalling specific bags of Brown Rice Flour because they have 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 if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
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Solgar, Inc. Issues Voluntary Class I Recall of ABC Dophilus Powder
Solgar, Inc., of Leonia, NJ, is voluntarily recalling ABC Dophilus Powder. The recall was initiated, out of an abundance of caution, because the product was found to contain Rhizopus oryzae, which may cause Mucormycosis. This is a rare infection that may cause health problems to consumers, particularly pre-mature infants/infants, children, and those with weakened immune systems.ÂÂ
B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product
B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products. There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.
Great American Appetizers, Inc. Recalls Hyvee Mozzarella Cheese Sticks Due To Undeclared Soy Flour, Yellow #5, And Yellow #6
Great American Appetizers, Inc. of Nampa, Idaho is recalling 662 cases of HyVee Mozzarella Cheese Sticks because they may contain undeclared soy flour, yellow #5 and yellow #6. People who have an allergy or sensitivity to soy, yellow #5 or yellow #6 can run the risk of serious allergic reaction if they consume this product.
Philips Healthcare Announces Recall of Children’s Medical Ventures Gel-E Donut / Squishon 2 Products
Children’s Medical Ventures, a Philips Healthcare business, today announced that the company has issued a recall of all Gel-E Donut gel pillow and Squishon 2 gel cushion products due to potential mold contamination of the products. This action follows a previous recall for these products announced in May 2014.