The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.
House of Flavors Issues Allergy Alert on Undeclared Pecans in Purple Cow Cookie Butter Ice Cream
House of Flavors, Inc. is voluntarily recalling a small batch of 8 oz. cups of Purple Cow Limited Edition Cookie Butter Ice Cream, sold at Meijer stores, that contain Purple Cow Butter Pecan Ice Cream with a Purple Cow Butter Pecan lid. Consumers who may have a severe allergy or sensitivity to nuts run the risk of potentially life-threatening allergic reaction if they consume this product.
House of Flavors Issues Allergy Alert on Undeclared Pecans in Purple Cow Cookie Butter Ice Cream
House of Flavors, Inc. is voluntarily recalling a small batch of 8 oz. cups of Purple Cow Limited Edition Cookie Butter Ice Cream, sold at Meijer stores, that contain Purple Cow Butter Pecan Ice Cream with a Purple Cow Butter Pecan lid. Consumers who may have a severe allergy or sensitivity to nuts run the risk of potentially life-threatening allergic reaction if they consume this product.
Figi’s Issues Recall Alert on Mislabeled Marzipan
Figi’s Companies, Inc. of Marshfield, WI is recalling 8 ounce packages of “Classic Marzipan” because the ingredients are not properly labeled and the product contains undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA Classifies St. Jude Medical Field Action For 447 Of The Company’s Optisure High Voltage Leads As A Class 1 Advisory In The U.S.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step.
Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter
Baxter International Inc. announced today it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events associated with these incidents reported to Baxter to date.
Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter
Baxter International Inc. announced today it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events associated with these incidents reported to Baxter to date.
AA USA Trading Inc. Issues Allergy Alert on Undeclared Sulfites and Colors in AA Brand Dried Kiwi and Dried Mango
AA USA Trading Inc. of South River, NJ is recalling is recalling both dried kiwi and dried mango products packaged under the AA brand in 8-ounce plastic bags, because they may contain undeclared sulfites and colors. People who have an allergy or severe sensitivity to sulfites or food colors run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA resolves criminal and civil actions against cheese manufacturer
Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.
FDA resolves criminal and civil actions against cheese manufacturer
Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.