The Knowledge Shelf

Unapproved New Drugs/Misbranded

Unapproved New Drugs/Misbranded

World Market is recalling EMEK SPREAD PISTACHIO CACAO CREAM WITH KADAYIF, 9.7oz, Best Before: April 01, 2027, Batch Number: 250401 due to a potential contamination of Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

Danone U.S. is voluntarily recalling YoCrunch® products sold at retail stores nationwide due to the potential presence of plastic pieces in the dome topper. If consumed, the plastic pieces could potentially cause a choking response. The issue is isolated only to the separately packaged topper and do

Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of serious or life-threatening allergic reactions if they consume these

Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP

PDUFA and BsUFA Quarterly Hiring Updates

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

LLK TRADING INC. of Linden, NJ, is recalling its 200g packages of “Needle Mushrooms” because it has the potential to be contaminated with Listeria monocytogenes

This page contains the Gastrointestinal roster, which lists the current members and the current number of vacancies for the committee.