During the outbreak of Salmonella Bareilly tied to spicy tuna sushi, , FDA’s urgent-response team shifted into high gear.
Read More
FDA Unit Mobilizes for Emergency Response
Reply
Certain Compounded Drugs from Franck’s: FDA Issues Second Warning to Physicians
[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.
Read More
FDA issues final rule on sterility testing of biological products
The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.
Read More
FDA permits marketing of a new device for abdominal surgery
On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.
The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.
Read More
FDA approves new orphan drug to treat a form of Gaucher disease
The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
Read More
Funfresh Foods, Inc. Voluntarily Recalls World Berries™ Organic “Cacao Nibs” Because of Possible Health Risk
FunFresh Foods, Inc. of San Clemente, California in consultation with the FDA is voluntarily recalling a single lot of its 6 ounce packages of FunFresh Foods™ World Berries™ Organic “Cacao Nibs” because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools.
Read More
FIGI’S INC. Issues Allergy Alert On Undeclared Almonds In Lemon Bar Bliss
Figi’s Inc, Marshfield, WI is recalling 51 units of the product Lemon Bar Bliss (1#tins), because it contains undeclared Almonds.
Read More
H-E-B Issues a Precautionary Recall For Asian Ready-to-Eat Meals due to Possible Health Risk
H-E-B has issued a voluntary and precautionary recall for certain Asian Ready-to-Eat meals due to the possibility of undercooked chicken in those meals. There have been no confirmed illnesses reported related to this precautionary recall.
Read More
Notice of Recall – Triamcinolone acetonide P.F. 80mg/ml
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall involved five physicians and eight prescriptions.
Read More
Church & Dwight Co., Inc. Voluntarily Recalls Select Lots of Spinbrush® Rechargeable SONIC Toothbrushes Distributed Between February 2010 and October 2011 for Possible Health Risk
Church & Dwight Co., Inc. is voluntarily recalling Spinbrush Rechargeable SONIC toothbrushes because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. The risk of these malfunctions appears to increase with the age of the product.
Read More