Hong Lee Trading Inc., NY, is recalling its CHAO CAFÉ VIETNAMESE INSTANT COFFEE MIXED 3 IN 1, 384 GRAM, CONTAINER CODE JUNE 06 2018, because they contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.
Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product
Condies Foods Issues Allergy Alert on Undeclared Milk and Egg allergen in Veggie Cup Item# 40781
Condies Foods of Kearns, UT is recalling 166 cases of code date “USE THRU 01/05/2018,” there is a possibility that this may contain undeclared milk and egg allergens. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume these products.
Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk
Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut 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 system. 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 in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.
Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial
AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.
California Popsicle, Inc. Issues Allergy Alert on Undeclared Milk in Ice Bars
California Popsicle, Inc. dba Polly Ann Ice Cream of South San Francisco, CA is recalling ice bars, because it may contain undeclared milk. 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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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).
T. Marzetti Company Voluntarily Recalls Frozen Biscuit Dough Packed Under Various Brands Due to Potential Listeria Contamination
As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.