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FDA Recalls


02/04/2012 01:11 PM
Healthy People Co. Issues a Voluntary Recall of Specific Lots of the Dietary Supplements Found to Contain Undeclared Drug Ingredients
Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers. Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.
02/04/2012 09:47 AM
Nest Collective Voluntarily Recalls Select Revolution Foods Jammy Sammy - Strawberry Jam & Peanut Butter Snack Size Sandwich Bars Due to a Labeling Error (Undeclared Peanut on Inner Wrapper)
Nest Collective ™ announced today that it is voluntarily recalling 8150 selling units of its Jammy Sammy™ - Strawberry Jam & Peanut Butter Flavor Snack Size Sandwich Bars due to a mislabeled inner wrapper. The cartons contain the best by date June 28, 2012 and are marked with the following universal product code (UPC) #89676600116 6 located on the bottom of the package.
02/03/2012 08:48 PM
California Firm Recalls Prepared Sandwiches that Contain Hard-Cooked Eggs
GH Foods CA, LLC was notified by their supplier that the eggs supplied to them were from Michael Foods, Inc, who recalled Hard-Cooked eggs due to potential contamination by Listeria monocytogenes. GH Foods CA, LLC, Sacramento, California, is therefore recalling sandwiches, associated with the affected eggs, due to potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems.
02/03/2012 01:32 PM
Greencore, USA – Cincinnati, Recalls Egg Salad Sandwiches with Brand Name Quick Café and Take Away Café because of Possible Health Risk
Greencore, USA is recalling approximately 550 pounds of egg salad sandwiches. The sandwiches contain eggs manufactured by Michael Foods Inc that are the subject of a previous recall due to possible contamination with Listeria Monocytogenes.
02/02/2012 06:56 PM
Allison’s Gourmet Kitchens Recalls Prepared Salads that Contain Hard Cooked Eggs Due to Potential Health Risk.
Allison’s Gourmet Kitchens was notified by their egg supplier, Michael Foods, Inc. that they are recalling numerous lots of their hard cooked eggs due to the potential for contamination by Listeria monocytogenes. Some of these eggs were introduced into our process to manufacture these effected products.
02/02/2012 02:20 PM
Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093
Bedford Laboratories, today issues updated guidance on the following nationwide voluntary product recall originally initiated on December 20, 2011
02/02/2012 01:23 PM
Wegmans Recalls Various Prepared Foods That Contain Hard-Cooked Eggs Produced by Michael Foods
Wegmans Food Markets, Inc. is recalling hard-cooked eggs, as well as prepared foods that contain hard-cooked eggs, sold between January 23 and February 1, 2012 because the eggs have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. 

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02/01/2012 06:48 AM
FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
01/31/2012 02:29 PM
FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
01/31/2012 07:59 AM
FDA approves Kalydeco to treat rare form of cystic fibrosis
The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
01/31/2012 07:13 AM
FDA takes action against New York cheese manufacturer
The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
01/30/2012 07:58 AM
FDA approves new treatment for most common type of skin cancer
Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).
01/27/2012 09:09 AM
FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
01/25/2012 01:59 PM
Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities
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