Palmer Candy Company (www.palmercandy.com), announced today a limited recall of Sea Salt Caramel Hearts that were only sold at Bomgaards Supply Inc. Store in the Midwest States. The voluntary recall, in cooperation with the U.S. Food and Drug Administration (FDA) due to abundance of caution of a possible peanut allergen contamination. People who have an […]
FOR IMMEDIATE RELEASE – 01-12-2018 – East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as […]
Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter.
Bellisio Foods, Inc., a Jackson, Ohio, manufacturer, is voluntarily recalling certain Michelina’s Fettuccine Alfredo due to the possibility some packages may contain undeclared chicken with soy that is not listed on packaging. People who have an allergy or sensitivity to soy may run the risk of serious allergic reaction(s) if they consume this product.
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA — that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish […]
FDA updates on some ongoing shortages related to IV fluids
The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals
Hiland Dairy is announcing a voluntary recall of two products produced at the Omaha, Nebraska facility, over concerns the products may contain milk protein that could affect those individuals that have sensitivity to milk allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if […]
Rico Brand of Salt Lake City, Utah is recalling Tofu Breakfast Burrito, because it may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy run the risk of serious or life-threatening allergic reaction if they consume these products.
: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
Fieldbrook Foods Corporation is clarifying that the previously announced 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) also includes 28,751 cases of Raspberry Cream Bars that were included with Orange […]
Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product.
January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile 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 […]
January 8, 2018 – Gilster-Mary Lee, 520 Old St. Mary’s Road, of Perryville, Missouri, is voluntarily recalling one lot of Essential Everyday® Coat & Bake Original Chicken coating, UPC 41303-01572 at the consumer level because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious […]
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes […]