FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and Distributed by Merrick Pet Care

The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of “Best By 111911” because the product may be contaminated with Salmonella.

The product was distributed nationwide through retail stores and Internet sales.

Although no illnesses associated with these products have been reported, the FDA is advising consumers in possession of these products not to handle or feed them to their pets.

In December 2009, the FDA conducted routine testing of Merrick Beef Filet Squares and detected a positive finding for Salmonella. A follow-up inspection found deficiencies in the packaging and manufacturing processes.

Salmonella can affect both humans and animals. People handling dry pet treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the treats or any surfaces exposed to these products. Consumers should dispose of these products in a safe manner by securing them in a covered trash receptacle.

Healthy people infected with Salmonella may experience some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Although rare, Salmonella can result in more serious ailments including arterial infections, endocarditis (inflammation of the lining of the heart), arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their health care provider immediately.

Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets may experience only a decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed any of the affected product or is experiencing any of these symptoms, contact your veterinarian immediately.

The affected Merrick Beef Filet Squares were packaged in a 10-ounce green, red and tan re-sealable plastic bag. The “best by” date is imprinted on the top portion of the bag, which is torn off when the bag is opened. The FDA recommends that consumers who are unable to determine the “best by” date discontinue use of the product.

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FDA Launches New Pet Health and Safety Widget

The U.S. Food and Drug Administration today launched its pet health and safety widget for consumers as part of an ongoing effort to provide timely, user-friendly, public health information.

“Our new pet health and safety widget provides users with information to help them in managing their pet’s health,” said Joshua Sharfstein, M.D., FDA’s principal deputy commissioner.

The widget, a portable application embedded in a Web page that can be copied onto any other Web site or blog, will include topics such as how to report a problem with your pet food, purchasing pet drugs online, and caring for your pet in a disaster. The widget allows users to access content on the FDA’s Web site without having to leave another site or Web page.

“The pet health and safety widget allows users to add a new dimension to their Web site by providing consumers with the latest news and information from the FDA’s Center for Veterinary Medicine,” said Bernadette Dunham, D.V.M., Ph.D., director of FDA’s Center for Veterinary Medicine.

The widget has two tabs, one titled “tips” and, the other, “updates. The Tips tab highlights pet health and safety articles. The Updates tab will provide up-to-the-minute recall notices and veterinary drug news for consumers.

The pet health and safety widget is available at www.fda.gov/PetHealthWidget requires no technical maintenance on the part of the user. The FDA will provide updates to content displayed on the widget.

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FDA Health Alert for Certain Pet Treats Made by Pet Carousel

The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif.

The products were manufactured under conditions that facilitate cross-contamination within batches or lots. Although no illnesses associated with these products have been reported, the FDA is advising consumers in possession of these products to not handle or feed them to their pets.

The affected pig ear products were packaged under the brand names Doggie Delight and Pet Carousel. The affected beef hooves were packaged under the brand names Choo Hooves, Dentley’s, Doggie Delight, and Pet Carousel. All sizes and all lots of these products made by Pet Carousel are included in this alert.

During September 2009, the FDA conducted routine testing of pig ears made by Pet Carousel. The test results detected a positive reading for Salmonella. This prompted an FDA inspection of Pet Carousel’s manufacturing facilities. During the inspection, the agency collected additional pet treat samples. Further analysis found Salmonella present in beef hooves, pig ears and in the manufacturing environment.

Salmonella can affect both humans and animals. People handling dry pet food and/or pet treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the treats or any surfaces exposed to these products. Consumers should dispose of these products in a safe manner by securing them in a covered trash receptacle.

Healthy people infected with Salmonella may experience some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Although rare, Salmonella can result in more serious ailments including arterial infections, endocarditis (inflammation of the lining of the heart), arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their health care provider immediately.

Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets may only experience a decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed any of the affected products or is experiencing any of these symptoms, contact your veterinarian immediately.

The FDA will continue to investigate this matter to determine the source of the Salmonella contamination and offer updates as appropriate.

Consumers can report complaints about FDA-regulated pet food and pet treat products by calling the consumer complaint coordinator in their area. You can locate the nearest consumer complaint coordinator at:
http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm

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FDA: First Drug to Treat Cancer in Dogs Approved

The U.S. Food and Drug Administration today announced the approval of Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs.

Palladia is approved to treat canine cutaneous (skin-based) mast cell tumors, a type of cancer responsible for about 1 out of 5 cases of canine skin tumors. The drug is approved to treat the tumors with or without regional lymph node involvement.

All cancer drugs now used in veterinary medicine originally were developed for use in humans and are not approved for use in animals. Cancer treatments used in animals are used in an “extra-label” manner as allowed by the Animal Medicinal Drug Use Clarification Act of 1994.

"This cancer drug approval for dogs is an important step forward for veterinary medicine," said Bernadette Dunham, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Prior to this approval, veterinarians had to rely on human oncology drugs, without knowledge of how safe or effective they would be for dogs. Today's approval offers dog owners, in consultation with their veterinarian, an option for treatment of their dog's cancer."

While canine mast cell tumors often appear small and insignificant, they can be a very serious form of cancer in dogs. Some mast cell tumors are easily removed without the development of any further problems, while others can lead to life threatening disease.

Palladia is a tyrosine kinase inhibitor and works in two ways: by killing tumor cells and by cutting off the blood supply to the tumor. In a clinical trial, Palladia showed a statistically significant difference in tumor shrinkage when compared with an inactive substance (placebo).

The most common side effects associated with Palladia are diarrhea, decrease or loss of appetite, lameness, weight loss, and blood in the stool.

Palladia is manufactured by Pfizer Animal Health Inc., New York City.

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FDA Issues Final Guidance on Regulating Genetically Engineered Animals

The U.S. Food and Drug Administration today issued a final guidance for industry on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," clarifies the FDA's statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it is called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

“Genetic engineering is a cutting edge technology that holds substantial promise for improving the health and well being of people as well as animals. In this document, the agency has articulated a scientifically robust interpretation of statutory requirements," said Randall Lutter, Ph.D., deputy commissioner for policy. “This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy."

The FDA released the draft guidance in September 2008 with a 60-day public comment period, and received about 28,000 comments. The agency has summarized and responded to these comments on the Web site listed below.

The FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals on both early stage and more mature applications.

“At this time, it is our intent to hold public scientific advisory committee meetings prior to making decisions on GE animal-related applications" said Bernadette Dunham, D.V.M., Ph.D., director of CVM.

The FFDCA defines “articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and any new products expressed from the inserted construct are safe for the health of the GE animal and, if they are food animals, for food consumption.

The guidance also describes the manufacturer's responsibility in meeting the requirements for environmental review under the National Environmental Policy Act.

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FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed

The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.

FDA has cited the defendants for numerous deviations from cGMP over the last five years. FDA inspected Milbank Mills four times during this period, and found gross deviations from cGMP that resulted in voluntary recalls of medicated animal feeds. Despite repeated warnings from FDA, the defendants have continued to manufacture medicated animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and its regulations.

Medicated animal feeds include specific types and amounts of drugs to prevent disease in food-producing animals, and failure to comply with cGMP requirements when manufacturing such feeds renders the product adulterated (or illegal). Among other cGMP violations, Milbank Mills repeatedly failed to store and handle drugs properly to maintain their effectiveness, did not maintain records of drug inventory and use, and did not adequately test its feed products to ensure that they contained the correct amounts of drugs. In addition, Milbank Mills did not accurately label its medicated feed products or provide adequate directions for their use.

Under the consent decree, failure to comply with the terms could result in civil or criminal penalties. Consumers who may have purchased adulterated feed from Milbank Mills should contact the company directly.

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Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY® Gourmet Sold at Wal-Mart locations in Fifteen States due to Pote

Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY® Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.

This product should not be sold or fed to pets. Pet owners should dispose of product in a safe manner (example, a securely covered trash receptacle) and return the empty bag to the store where purchased for a full refund.

Salmonella can cause serious infections in dogs and cats, and, if there is cross contamination caused by handling of the pet food, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

There have been no complaints or reports of illness resulting from consumption or handling of the recalled product.

Pet owners who have questions about the recall should call 1-877-568-4463 or visit www.petcare.mars.com.

Recalled Pet Food
Product: SPECIAL KITTY® Gourmet Blend Dry Cat Food
Best If Used By Date: AUG 11 09
Best If Used By Date Location: Back of bag
Production Lot Code: 50 XXXX X (Found on back of bag just after "Best If Used By" date. Consumers should look for "50" as the first two digits of the second line.)
UPC Code: UPC code numbers can be found directly underneath the bar code on the package. Please find recalled pet food UPC information below.

3.5 lb.


SPECIAL KITTY® Gourmet Blend


81131 17546

7 lb.


SPECIAL KITTY® Gourmet Blend


81131 17547

18 lb.


SPECIAL KITTY® Gourmet Blend


81131 17548

Affected Stores: Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia.

In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets. A list of safe pet food handling tips can be found at: www.fda.gov/consumer/updates/petfoodtips080307.html

Pet owners who have questions about the recall should call 1-877-568-4463 or visit www.petcare.mars.com.

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The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk

The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.

Salmonella can cause serious infections in dogs, and, if there is cross-contamination caused by handling of the rawhide chips, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and can potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The product involved is 4,850 - 2 pound plastic bags of Hartz Chicken-Basted Rawhide Chips, lot code JC23282, UPC number 3270096463 which were distributed to a national retail customer. While the normal testing that Hartz conducts through an independent outside laboratory did not detect the presence of Salmonella in any Hartz rawhide products, sample testing conducted by another laboratory did indicate the presence of the bacteria in a sample bag of the Chicken-Basted Rawhide Chips. Hartz is aggressively investigating the difference in test results and the potential source of the problem.

Although Hartz has not received any reports of animals or humans becoming ill as a result of coming into contact with this product, Hartz is taking immediate steps to remove the product from all retail stores and distribution centers. Dog owners who purchased this product should check the lot code on their bag, and, if the code is not visible, or if the bag has lot code JC23282 imprinted thereon, they should immediately discontinue use of the product and discard it in a proper manner.

Consumers can contact Hartz at 1-800-275-1414 with any questions they may have and to obtain reimbursement for purchased product.

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FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it's called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure).

Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.

Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the U.S. food supply unless the FDA has authorized such use.

The FD&C Act classifies "articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and intended to affect the animal's structure or function meets the definition of a new animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and/or any new products expressed from the inserted construct are safe for the health of the GE animal.

Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.

The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act.

Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the U.S. Department of Agriculture (USDA) and with other federal departments and agencies, such as the Environmental Protection Agency, in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology. USDA has published in the same issue of the Federal Register a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock.

"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach."

The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.

The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.

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Safe Handling Advice for Pet Foods and Treats from the FDA

Consumers can take steps to help prevent foodborne illness, including Salmonella -related illness, when handling pet foods and treats. These products, like many other types of foods, can be susceptible to harmful bacterial contamination.

Salmonella in pet foods and treats can cause serious infections in dogs and cats, and in people too, especially children, older people, and those with compromised immune systems. Salmonella in pet foods and treats potentially can be transferred to people ingesting or handling the contaminated products.

FDA has stepped up its efforts to minimize the incidence of foodborne illness associated with pet foods and treats. Pet owners and consumers can also help reduce the likelihood of infection from contaminated pet foods and treats by following safe handling instructions:

Buying

* Purchase products in good condition, without signs of damage to the packaging such as dents or tears.

Preparation

* Wash your hands for 20 seconds with hot water and soap before and after handling pet foods and treats.
* Wash pet food bowls, dishes, and scooping utensils with soap and hot water after each use.
* Do not use the pet's feeding bowl as a scooping utensil—use a clean, dedicated scoop or spoon.
* Dispose of old or spoiled pet food products in a safe manner, such as in a securely tied plastic bag in a covered trash receptacle.

Storage

* Refrigerate promptly or discard any unused, leftover wet pet food. Refrigerators should be set at 40º F.
* Dry products should be stored in a cool, dry place—under 80º F.
* If possible, store dry pet food in its original bag inside a clean, dedicated plastic container with a lid, keeping the top of the bag folded closed.
* Keep pets away from food storage and preparation areas.
* Keep pets away from garbage and household trash.

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Mars Petcare US Issues Voluntary Recall of Everson, PA Plant Dry Pet Food Product due to Potential Salmonella Contamination

Today, Mars Petcare US announced a voluntary recall of products manufactured at its Everson, Pennsylvania facility. The pet food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund. This voluntary recall only affects the United States.

Salmonella can cause serious infections in dogs and cats, and, if there is cross contamination caused by handling of the pet food, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and can potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The company stopped production at the Everson facility on July 29, 2008 when it was alerted of a possible link between dry pet food produced at the plant and two isolated cases of people infected with Salmonella Schwarzengrund.

Even though no direct link between product produced at Everson and human or pet illness has been made, Mars Petcare US is taking precautionary action to protect pets and their owners by announcing a voluntary recall of all products produced at the Everson facility beginning February 18, 2008 until July 29, 2008 when we stopped production.

The company is continuing to work collaboratively with the FDA to determine the nature and source of Salmonella Schwarzengrund at the Everson facility. Since it has not yet identified the source of the Salmonella Schwarzengrund at the Everson facility, Mars Petcare US does not plan to resume production out of a commitment to the safety of our pet owners and their pets, customers, and associates.

The top priority of Mars Petcare US has always been and continues to be the health and welfare of pets and their owners. Consumers can continue to have confidence in the quality and safety of the products produced at other Mars Petcare US facilities. Only those products which were produced at the Everson facility are impacted by the voluntary recall.

Many of the brands involved in the recall are national brands produced at multiple facilities. A chart for all products is below. For example, PEDIGREE® is manufactured in numerous facilities throughout the country, and Everson represents a very small portion of the manufacturing base – 2.7 percent of total PEDIGREE® production.

Mars Petcare US will work with retail customers to ensure that the recalled products are not on store shelves. These products should not be sold or fed to pets. In the event that consumers believe they have purchased products affected by this voluntary recall, they should return the product to the store where they purchased it for a full refund. Specific product details and other information can be found at www.petcare.mars.com

Please find recalled pet food UPC information below.

The products listed below are made at our Everson facility on behalf of a variety of retailers. All code dates, with the exception of PEDIGREE®, are listed in a similar format as noted below:
Consumers should look for “17” as the first two digits of the second line. Sample:
Best By Feb 18 09
17 1445 1

For PEDIGREE® the Everson code date format is as follows:

Consumers should look for “PAE” on the bottom line – the sixth, seventh and eighth digits. Sample:
PEDIGREE ® Small Crunchy Bites
Best Before 02/2009
808G1PAE01 12:00

In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets.

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FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term "insanitary" to describe such conditions).

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."

The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.

As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.

If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.

FDA Announces Limited Return of Heartworm Drug to U.S. Market

The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.

ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.

"This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs," said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. "While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions."

Heartworm disease is a serious and potentially fatal condition for dogs. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.

The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product.

The return of ProHeart 6 to the market is based on results of additional toxicological and pharmacologic studies by Fort Dodge Animal Health coupled with the low adverse reaction frequency in international markets.

In 2004, Fort Dodge Animal Health agreed to voluntarily recall the product from the market based upon FDA's concerns regarding reports of serious adverse reactions in dogs following the use of ProHeart 6. In response to FDA's concerns, the manufacturer conducted additional testing of its product, which indicated that residues of the solvents used in the manufacture of ProHeart 6 may cause allergic reactions.

The manufacturer has improved the manufacturing specifications for ProHeart 6 to decrease the presence of those residues and has marketed the product in international markets. Few adverse events have been reported with this reformulated product.

The ProHeart 6 label and Client Information Sheet have been revised to include updated safety information. The new label includes warnings not to administer the drug within one month of vaccinations, and to use the product with caution in dogs with pre-existing allergic diseases including food allergies, allergic hypersensitivity, and flea allergy dermatitis. The label also warns against administering the drug to dogs who are sick, debilitated, underweight, or who have a history of weight loss. In addition, the label’s Post-Approval Experience section has been updated to include information about adverse reactions based on voluntary post-approval drug experience reporting.

Dog owners who suspect their dog is experiencing an adverse reaction to ProHeart 6 should immediately contact their veterinarian to initiate appropriate veterinary care. Veterinarians should contact Fort Dodge Animal Health to report any adverse events at (800) 533-8536.