FDA Weekend Update;Skippy,Hazelnuts,Raw Vitamin C,"Crack Down"Unapproved prescription cough, cold, or allergy products "

Unilever Announces Recall of Skippy®

Reduced Fat Peanut Butter Spread Due to Possible Health Risk Limited Recall of 6 Best-If-Used-By Dates

Contact:Media Contact: Anita Larsen201-894-7760Consumers:800-453-3432

FOR IMMEDIATE RELEASE - March 4, 2011 -
Unilever United States, Inc. today announced a limited recall of Skippy® Reduced Fat Creamy Peanut Butter Spread and Skippy® Reduced Fat Super Chunk Peanut Butter Spread, because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA). No other Skippy® products are affected by this recall.
The product was distributed to retail outlets in Arkansas, Connecticut, Delaware, Illinois, Iowa, Maine, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Pennsylvania, Virginia and Wisconsin.
The affected product, which is packaged in 16.3 oz plastic jars, is as follows:
UPCs: 048001006812 and 048001006782 (located on the side of the jar’s label below the bar code.)
Best-If-Used-By Dates: MAY1612LR1, MAY1712LR1, MAY1812LR1, MAY1912LR1, MAY2012LR1 and MAY2112LR1 (Stamped on the lid of the jar.)

To date, no illnesses related to this issue have been reported.
The recall was initiated as the result of a routine sampling program by the company, which revealed that these finished products may contain the bacteria.
Consumers who have purchased Skippy® Reduced Fat Peanut Butter Spread with the above UPCs and Best-If-Used-By-Dates are urged to discard the product immediately and call the company for a replacement coupon. Consumers can contact the company at 1-800-453-3432, which is operational 24 hours a day, for information on the recall. In addition, a consumer services representative is available Monday through Friday between the hours of 8:30 AM and 6:00 PM EST.

Hazelnuts Linked to Three-State E. Coli Outbreak
March 5th
WASHINGTON) -- Three states and the federal government are investigating an outbreak of E. coli linked to in-shell hazelnuts purchased from bulk food bins at grocery stores. Seven cases have been reported, according to the Minnesota Department of Health, one agency involved in the investigation. Minnesota and Wisconsin both had three cases and one case was reported in Michigan. "Agriculture agencies in the three states and the California Department of Public Health traced hazelnuts consumed by cases to a common distributor in California, DeFranco and Sons," the Minnesota Department of Health said in a statement Friday. "This firm has recalled all hazelnut and mixed nut products distributed from November 2, 2010, to December 22, 2010. Recalled product was shipped to stores in Minnesota, Iowa, Michigan, Montana, North Dakota, South Dakota, and Wisconsin.”Consumers are advised to visit the Minnesota Department of Agriculture's website for a full list of stores that sold the nuts.
Copyright 2011 ABC News Radio

See FDA site for complete information; DeFranco and Sons Recall Bulk and Consumer-packaged In-shell, Hazelnut and Mixed Nut Products Containing Hazelnuts

DeFranco and Sons received the in-shell nuts from suppliers or growers and subsequently distributed the nuts nationwide and to Canada. The affected nuts listed below were distributed between 11/2/10 and 12/22/10.

Brand........Size........Product .......Sell By Date
Sunripe..... 1 lb....... Hazelnuts..,.... 6/30/11
Sunripe......1 lb...Large Hazelnuts..6/30/11
Sunripe......2 lb.....Mixed Nuts.....,..6/30/11
Sunripe......4 lb.......Hazelnuts.........6/30/11
Sunripe....50 lb.......Hazelnuts........None
Sunripe....50 lb.......Hazelnuts........None
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George Packing..50 lb...Hazelnuts
Only the products distributed by DeFranco and Sons between 11/2/10 to 12/22/10.
Firestorm Farms...50 lb....Hazelnuts.
Northwest Hazelnuts...50 lb..Hazelnuts


March 02, 2011 -
Garden of Life, LLC. Issues a Voluntary Recall of Vitamin Code Raw Vitamin C Dietary Supplement. Recall is Limited to Raw Vitamin C Only. No Other Garden of Life Products are Involved.24

Contact:Consumers - GOL Consumer Support Team: 866-465-0051Retailers - GOL Retail Support Team: 866-465-0052Media Relations:Amélie GermainDirector of CommunicationsTel.: 418 652-1116

FOR IMMEDIATE RELEASE - West Palm Beach, FL, March 2, 2011 - Garden of Life, LLC today announced that it is voluntarily recalling its Raw Vitamin C because these products may contain undeclared soy proteins.
Consumers who have purchased Raw Vitamin C and are sensitive to soy should stop taking the product. According to the FDA less than 0.2% of children and adults are sensitive to soy. Further, most people outgrow the allergy after early childhood; however, adults allergic to soy may experience upset stomach, discomfort, and, in rare cases, serious and life threatening allergic reactions.
No illnesses have been reported in connection with the Raw Vitamin C.
It has come to Garden of Life’s attention that one of our unaffiliated third party manufacturers for this product also processes soy in its facilities. Because Raw Vitamin C does not utilize any ingredients originally derived from soy, we were surprised to learn that some bottles of our Raw Vitamin C tested positive for significant amounts of soy proteins.
How to Identify the Recalled Product: To avoid any consumer confusion, this VOLUNTARY ACTION only extends to Garden of Life’s product bearing the name “VITAMIN CODE RAW VITAMIN C” prominently displayed on both the outer carton as well as the bottle label. All Lots of Raw Vitamin C distributed between March 2009 and January 2011 or remaining in expiry are subject to this voluntary recall.
No other Garden of Life products are involved with this voluntary recall.
Raw Vitamin C has been sold nationally to traditional health food stores and through internet retailers.
Any consumers concerned with soy and not fully satisfied with their Raw Vitamin C purchase should return the unused portion of the product to the place of purchase for a full refund. Questions may be directed to the company at 1-866-465-0051, Monday-Friday between the hours of 9:00 AM and 5:00 PM EST
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FDA cracks down on unapproved prescription oral cough, cold, and allergy products

For Immediate Release: March 2, 2011 Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.govConsumer Inquiries: 888-INFO-FDA
FDA prompts removal of unapproved drugs from market Class action is part of FDA’s Unapproved Drugs Initiative

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.
Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval. “Removing these unapproved products from the market will reduce potential risks to consumers,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products.” Companies that have previously listed products subject to today’s action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days. Companies that have not previously listed products subject to today’s action with FDA are expected to stop manufacturing and shipping their products immediately.
Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed OTC, taking an unapproved prescription product is an unnecessary risk. Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative1, which began in June 2006. The initiative is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process. One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of unapproved prescription cough, cold, and allergy products to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch2 or by calling 800-332-1088.

Unapproved Prescription Cough, Cold, and Allergy Products Federal Register Notice (PDF)3
List of Unapproved Prescription Cough, Cold, and Allergy Drug Products Affected by Today’s Action, Based on Firm's Listing with FDA 4
Unapproved Drugs Enforcement Actions (By Drug Class) 5
Consumer Health Update: FDA Intends to Remove Unapproved Drugs from the Market (March 2, 2011)6
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U.S. FDA Removes Warning About Potential Liver Injury From Boxed Warning Of Prescribing Information For Gilead's Letairis
05 March 2011
Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a change to the prescribing information for Letairis(R) (ambrisentan 5 mg and 10 mg tablets), the company's...
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Recalls, Market Withdrawals, & Safety Alerts
This page provides a listing of product actions within the last 60 days. The list consists mainly Class I recalls or other actions and notices that have been taken to correct or remove products from the market that may potentially present a significant or serious risk of injury or death if used or eaten or that, for other reasons, are of considerable interest to the public.