The health of our nation’s children is a responsibility that the FDA takes very seriously. Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must undergo medical procedures that require anesthesia or sedation drugs have similar concerns.
FDA takes action on applications seeking to market modified risk tobacco products
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.
FDA takes action on applications seeking to market modified risk tobacco products
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.
Linden Cookies Issues Allergy Alert on Undeclared Milk in Mini Chocolate Chip Cookies and 3 Pack Chocolate Chip Cookies
Linden Cookies, Inc. in Congers New York is recalling fully baked Linden’s Chocolate Chip Cookies because they contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
Brand Castle, LLC Recalls Limited Quantities of 16oz. Boxes of In The Mix® Monkey Bread Mix Due to Possible Salmonella Contamination
Brand Castle, LLC of Bedford Heights, Ohio is voluntarily recalling limited quantities of our In the Mix® Monkey Bread Mix because it has the potential to be contaminated with Salmonella
Brand Castle, LLC Recalls Limited Quantities of 16oz. Boxes of In The Mix® Monkey Bread Mix Due to Possible Salmonella Contamination
Brand Castle, LLC of Bedford Heights, Ohio is voluntarily recalling limited quantities of our In the Mix® Monkey Bread Mix because it has the potential to be contaminated with Salmonella
Fourth Street Barbecue, Inc. /Packing Division Recalls Mac & Cheese Dinner Cups Because of Possible Health Risk
Fourth Street Barbecue Inc./ Packing Division has initiated the voluntary recall of Cheese Club Express Mac & Cheese 4 cup dinner and Double Takes Macaroni & Cheese 2 cup dinner due to possible health risk. The powdered cheese packets may be impacted by milk powder ingredients recalled by Valley Milk Products, LLC contaminated with Salmonella.
Lenny & Larry’s, Inc. Conducts Nationwide Voluntary Recall of Chocolate Chip and Coconut Chocolate Chip Complete Cookie Recall Due To Possible Undeclared Milk in Dark Chocolate Chips
Lenny & Larry’s, Inc., announced today a nationwide voluntary recall of two flavors of Lenny & Larry’s Complete Cookie products — Chocolate Chip and Coconut Chocolate Chip varieties – due to the possible presence of undeclared milk in the dark chocolate chips. Lenny & Larry’s, Inc. is taking this action out of an abundance of caution. People with a dairy allergy or sensitivity may run the risk of a serious or life threatening allergic reaction if they consume these products.