Archive for the ‘Food & Drug Recalls’ category

International Laboratories, LLC Issues Voluntary Nationwide Recall of one (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in bottles of 30 tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

January 10, 2018

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

Wells Collection Inc Issues Alert On Undeclared Sulfites In Rely Brand Dried Longya Lily

January 10, 2018

Wells Collection Inc of Brooklyn, NY, is recalling its 8 ounce packages of Rely Brand Dried Longya Lily because the product contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

Fieldbrook Foods Corporation, Announces an Extension of Voluntary Recall of Orange Cream Bars and Chocolate Coated Vanilla Ice Cream Bars for Possible Health Risk

January 9, 2018

Fieldbrook Foods Corporation has issued a voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant code 362677). This is the only production line and the only Fieldbrook Foods plant (of 3) involved in […]

Dollar General Announces Voluntary Recall of Clover Valley® Iced Oatmeal Cookies Over Undeclared Milk and Tree Nuts

January 9, 2018

Dollar General Corporation announced a voluntary recall of its 12-ounce packages of Clover Valley® Iced Oatmeal Cookies with lot # L46217 30 with a best-by date of August 18, 2018 over concerns of undeclared milk and tree nuts. Consumers with a milk and/or nut allergy or sensitivity to these items should not consume these products […]

Fieldbrook Foods Corporation, Announces a Voluntary Recall of Orange Cream Bars for Possible Health Risk

January 5, 2018

Fieldbrook Foods Corporation of Dunkirk NY has issued a voluntary recall of 20 cases of the Tops brand of Orange Cream Bars and 320 cases of the Meijer Purple Cow brand Orange Cream Bars due to the possibility that the product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes […]

Hong Lee Trading Inc. Issues Allergen Alert on Undeclared Milk Allergens in Chao Café Vietnamese Instant Coffee Mixed 3 in 1

January 5, 2018

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

January 4, 2018

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

January 4, 2018

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 […]

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell

January 4, 2018

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

January 4, 2018

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

January 4, 2018

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, […]

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

January 3, 2018

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 […]

California Popsicle, Inc. Issues Allergy Alert on Undeclared Milk in Ice Bars

January 3, 2018

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. Read The Complete Story!

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

January 3, 2018

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

January 2, 2018

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 […]

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance

January 2, 2018

December 27, 2017 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, […]

New Seasons Market Issues Allergy Alert on Undeclared Egg in Packaged Macaroni and Cheese

December 29, 2017

New Seasons Market has initiated a voluntary recall of its New Seasons Market Grab and Go pre-packaged Macaroni and Cheese because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of an allergic reaction if they consume this product.

Daisy’s Bakery Inc. Issues Alert On Undeclared Milk In “Gourmet Concha”

December 28, 2017

Daisy’s Bakery Inc. of Clifton, New Jersey is recalling 4 ounce packages of Gourmet Concha, 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.

FDA permits marketing of device to treat diabetic foot ulcers

December 28, 2017

FDA permits marketing of device to treat diabetic foot ulcers

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