FDA Alerts

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

urobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules. Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.

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Kozy Shack Enterprises, LLC Issues Allergen Alert on Unlabeled Foodservice Chocolate Pudding Cups

Kozy Shack Enterprises, LLC is voluntarily recalling certain items of its Foodservice Kozy Shack Simply Well Chocolate Pudding 4 oz. cups because they contain undeclared milk and lack product labeling. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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Baxter Initiate Voluntary Recall of One Lot of Highly COncentrated Potassium Chloride Injection In The U.S. Due to Mislabeled Overpouch

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

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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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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.

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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.

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